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Cristina Solomon - One of the best experts on this subject based on the ideXlab platform.

  • effects of Fibrinogen Concentrate on thrombin generation thromboelastometry parameters and laboratory coagulation testing in a 24 hour porcine trauma model
    Clinical and Applied Thrombosis-Hemostasis, 2016
    Co-Authors: Christian Zentai, Cristina Solomon, Jonas Schnabel, Rolf Rossaint, Henri M. H. Spronk, Paola E J Van Der Meijden, Oliver Grottke
    Abstract:

    Introduction:In a 24-hour porcine model of liver injury, we showed that Fibrinogen supplementation does not downregulate endogenous Fibrinogen synthesis. Here we report data from the same study showing the impact of Fibrinogen on coagulation variables.Materials and Methods:Coagulopathy was induced in 20 German land race pigs by hemodilution and blunt liver injury. Animals randomly received Fibrinogen Concentrate (100 mg/kg) or saline. Coagulation parameters were assessed and thromboelastometry (ROTEM) was performed.Results:Fibrinogen Concentrate significantly reduced the prolongations of EXTEM clotting time, EXTEM clot formation time, and prothrombin time induced by hemodilution and liver injury. A decrease in clot strength was also ameliorated. Endogenous thrombin potential was significantly higher in the Fibrinogen group than in the control group, 20 minutes (353 ± 24 vs 289 ± 22 nmol/L·min; P < .05) and 100 minutes (315 ± 40 vs 263 ± 38 nmol/L·min; P < .05) after the start of infusion. However, no sign...

  • Severe pediatric blunt trauma–successful ROTEM-guided hemostatic therapy with Fibrinogen Concentrate and no administration of fresh frozen plasma or platelets. Clin Appl Thromb Hemost
    2016
    Co-Authors: Bernhard Ziegler, Christa Schimke, Peter Marchet, Cristina Solomon
    Abstract:

    Use of allogeneic blood products to treat pediatric trauma may be challenged, particularly in relation to safety. We report successful treatment of a child with severe abdominal and pelvic injuries with preemptive Fibrinogen supplementation followed by rotational thromboelastometry (ROTEM)-guided, goal-directed hemostatic therapy. Fibrinogen Concentrate was administered (total dose: 2 g), while transfusion of fresh frozen plasma and platelet Concentrate was avoided. Activated partial thromboplas-tin time was prolonged and Quick values were low but ROTEM clotting time values remained normal, therefore, no thrombin-generating drugs were considered necessary. This case shows the potential for hemostatic treatment with coagulation factor Concentrates to be applied to pediatric trauma

  • Testing in a 24-Hour Porcine Trauma Model
    2016
    Co-Authors: Christian Zentai, Cristina Solomon, Jonas Schnabel, Rolf Rossaint, Henri M. H. Spronk, Oliver Grottke
    Abstract:

    Introduction: In a 24-hour porcine model of liver injury, we showed that Fibrinogen supplementation does not downregulate endogenous Fibrinogen synthesis. Herewe report data from the same study showing the impact of Fibrinogen on coagulation variables. Materials and Methods: Coagulopathy was induced in 20 German land race pigs by hemodilution and blunt liver injury. Animals randomly received Fibrinogen Concentrate (100 mg/kg) or saline. Coagulation parameters were assessed and thromboelastometry (ROTEM) was performed. Results: Fibrinogen Concentrate significantly reduced the prolongations of EXTEM clotting time, EXTE

  • safety of Fibrinogen Concentrate analysis of more than 27 years of pharmacovigilance data
    Thrombosis and Haemostasis, 2014
    Co-Authors: Cristina Solomon, A Groner, I Pendrak
    Abstract:

    Fibrinogen Concentrate use as a haemostatic agent has been increasingly explored. This study evaluates spontaneous reports of potential adverse drug reactions (ADRs) that occurred during postmarketing pharmacovigilance of Haemocomplettan P/RiaSTAP, and reviews published safety data. This descriptive study analysed postmarketing safety reports recorded in the CSL Behring pharmacovigilance database from January 1986 to December 2013. A literature review of clinical studies published during the same period was performed. Commercial data indicated that 2,611,294 g of Fibrinogen Concentrate were distributed over the pharmacovigilance period, corresponding to 652,824 standard doses of 4 g each, across a range of clinical settings and indications. A total of 383 ADRs in 106 cases were reported (approximately 1 per 24,600 g or 6,200 standard doses). Events of special interest included possible hypersensitivity reactions in 20 cases (1 per 130,600 g or 32,600 doses), possible thromboembolic events in 28 cases (1 per 93,300 g or 23,300 doses), and suspected virus transmission in 21 cases (1 per 124,300 g or 31,000 doses). One virus transmission case could not be analysed due to insufficient data; for all other cases, a causal relationship was assessed as unlikely due to negative polymerase chain reaction tests and/or alternative explanations. The published literature revealed a similar safety profile. In conclusion, underreporting of ADRs is a known limitation of pharmacovigilance. However, the present assessment indicates that Fibrinogen Concentrate is administered across a range of indications, with few ADRs and a low thromboembolic event rate. Overall, Fibrinogen Concentrate showed a promising safety profile.

  • theoretical modelling of Fibrinogen supplementation with therapeutic plasma cryoprecipitate or Fibrinogen Concentrate
    BJA: British Journal of Anaesthesia, 2014
    Co-Authors: Peter Collins, Gerald Hochleitner, Herbert Schochl, Cristina Solomon, K Sutor, D Crispin, S Rizoli, Marco Ranucci
    Abstract:

    Background We aimed to create a theoretical tool to model the effect of three haemostatic agents containing Fibrinogen (therapeutic plasma, cryoprecipitate, and Fibrinogen Concentrate) on the patient's plasma Fibrinogen level. Methods A mathematical model was developed step-wise. The relationship between the amount of haemostatic agent and plasma Fibrinogen level was plotted for each agent. A Fibrinogen concentration simulator (FCSamount) was developed, where the amount of haemostatic agent was calculated from patient characteristics, agent characteristics, and target plasma Fibrinogen level. Refinements were introduced so that (i) FCSamount would account for in vivo Fibrinogen recovery, (ii) circulatory volume would not increase ad infinitum with increasing amounts, and (iii) red blood cells would be included in the simulation if haematocrit decreased below a certain level. A second FCS (FCSlevel) was created to calculate Fibrinogen levels resulting from specified amounts of haemostatic agents. Results Fibrinogen concentration in haemostatic agents has a critical impact on their ability to increase patients' Fibrinogen levels. If the target plasma Fibrinogen level approaches the concentration of the Fibrinogen source, the required amounts increase exponentially; it is impossible to achieve a target above the concentration of the Fibrinogen source. Conclusions We successfully developed two theoretical tools answering the questions: ‘How much therapeutic plasma, cryoprecipitate, or Fibrinogen Concentrate would be needed to achieve a specified target Fibrinogen level?' and ‘What would be the resultant Fibrinogen level for a specified amount of haemostatic agent?' The current tools are not intended for clinical application, but they are potentially useful for educational purposes.

Enny Sorense - One of the best experts on this subject based on the ideXlab platform.

  • effects of Fibrinogen Concentrate as first line therapy during major aortic replacement surgery a randomized placebo controlled trial
    Anesthesiology, 2013
    Co-Authors: Niels Rahemeye, Enny Sorense, Cristina Solomo, Christia Hagl, Dirk S Schmid, Dietrich Knoerze, Gerald Hochleitne, Alexander A Hanke, Maximilia Pichlmaie
    Abstract:

    BACKGROUND Fibrinogen is suggested to play an important role in managing major bleeding. However, clinical evidence regarding the effect of Fibrinogen Concentrate (derived from human plasma) on transfusion is limited. The authors assessed whether Fibrinogen Concentrate can reduce blood transfusion when given as intraoperative, targeted, first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. METHODS In this single-center, prospective, placebo-controlled, double-blind study, patients aged 18 yr or older undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to Fibrinogen Concentrate or placebo, administered intraoperatively. Study medication was given if patients had clinically relevant coagulopathic bleeding immediately after removal from cardiopulmonary bypass and completion of surgical hemostasis. Dosing was individualized using the fibrin-based thromboelastometry test. If bleeding continued, a standardized transfusion protocol was followed. RESULTS Twenty-nine patients in the Fibrinogen Concentrate group and 32 patients in the placebo group were eligible for the efficacy analysis. During the first 24 h after the administration of study medication, patients in the Fibrinogen Concentrate group received fewer allogeneic blood components than did patients in the placebo group (median, 2 vs. 13 U; P < 0.001; primary endpoint). Total avoidance of transfusion was achieved in 13 (45%) of 29 patients in the Fibrinogen Concentrate group, whereas 32 (100%) of 32 patients in the placebo group received transfusion (P < 0.001). There was no observed safety concern with using Fibrinogen Concentrate during aortic surgery. CONCLUSIONS Hemostatic therapy with Fibrinogen Concentrate in patients undergoing aortic surgery significantly reduced the transfusion of allogeneic blood products. Larger multicenter studies are necessary to confirm the role of Fibrinogen Concentrate in the management of perioperative bleeding in patients with life-threatening coagulopathy.

  • clinical effectiveness of fresh frozen plasma compared with Fibrinogen Concentrate a systematic review
    Critical Care, 2011
    Co-Authors: Sibylle Kozeklangenecke, Enny Sorense, John R Hess, Dona R Spah
    Abstract:

    Haemostatic therapy in surgical and/or massive trauma patients typically involves transfusion of fresh frozen plasma (FFP). Purified human Fibrinogen Concentrate may offer an alternative to FFP in some instances. In this systematic review, we investigated the current evidence for the use of FFP and Fibrinogen Concentrate in the perioperative or massive trauma setting. Studies reporting the outcome (blood loss, transfusion requirement, length of stay, survival and plasma Fibrinogen level) of FFP or Fibrinogen Concentrate administration to patients in a perioperative or massive trauma setting were identified in electronic databases (1995 to 2010). Studies were included regardless of type, patient age, sample size or duration of patient follow-up. Studies of patients with congenital clotting factor deficiencies or other haematological disorders were excluded. Studies were assessed for eligibility, and data were extracted and tabulated. Ninety-one eligible studies (70 FFP and 21 Fibrinogen Concentrate) reported outcomes of interest. Few were high-quality prospective studies. Evidence for the efficacy of FFP was inconsistent across all assessed outcomes. Overall, FFP showed a positive effect for 28% of outcomes and a negative effect for 22% of outcomes. There was limited evidence that FFP reduced mortality: 50% of outcomes associated FFP with reduced mortality (typically trauma and/or massive bleeding), and 20% were associated with increased mortality (typically surgical and/or nonmassive bleeding). Five studies reported the outcome of Fibrinogen Concentrate versus a comparator. The evidence was consistently positive (70% of all outcomes), with no negative effects reported (0% of all outcomes). Fibrinogen Concentrate was compared directly with FFP in three high-quality studies and was found to be superior for > 50% of outcomes in terms of reducing blood loss, allogeneic transfusion requirements, length of intensive care unit and hospital stay and increasing plasma Fibrinogen levels. We found no Fibrinogen Concentrate comparator studies in patients with haemorrhage due to massive trauma, although efficacy across all assessed outcomes was reported in a number of noncomparator trauma studies. The weight of evidence does not appear to support the clinical effectiveness of FFP for surgical and/or massive trauma patients and suggests it can be detrimental. Perioperatively, Fibrinogen Concentrate was generally associated with improved outcome measures, although more high-quality, prospective studies are required before any definitive conclusions can be drawn.

  • a critical evaluation of cryoprecipitate for replacement of Fibrinogen
    British Journal of Haematology, 2010
    Co-Authors: Enny Sorense, David Eva
    Abstract:

    Maintaining the plasma Fibrinogen concentration is important to limit excessive perioperative blood loss. This article considers the evidence for this statement, and questions the justification for using cryoprecipitate rather than virus-inactivated Fibrinogen Concentrate to support plasma Fibrinogen levels. Haemophilia was historically treated with cryoprecipitate, but specific coagulation factor Concentrates are now preferred. In contrast, primary fractions of allogeneic donor blood, including cryoprecipitate, are still commonly used to treat perioperative bleeding. When compared with cryoprecipitate and fresh-frozen plasma (FFP), freeze-dried Fibrinogen Concentrate offers standardized Fibrinogen content, faster reconstitution and improved efficacy. Pasteurization and purification processes employed in the preparation of Fibrinogen Concentrate reduce the risk of pathogen transmission and immune-mediated complications, in comparison with cryoprecipitate and FFP. When all costs associated with administration are taken into consideration, the cost of Fibrinogen Concentrate is not substantially different to that of cryoprecipitate. In conclusion, wider availability and use of Fibrinogen Concentrate may improve the management of perioperative bleeding. Further benefits may accrue from more rapid and accurate techniques for monitoring Fibrinogen levels. Clinical studies are needed to evaluate methods of measuring Fibrinogen and assessing fibrin polymerization, and to define critical haemostatic plasma Fibrinogen concentrations in different perioperative situations.

  • Fibrinogen Concentrate substitution therapy in patients with massive haemorrhage and low plasma Fibrinogen concentrations
    BJA: British Journal of Anaesthesia, 2008
    Co-Authors: Christia Fengererikse, Enny Sorense, M Lindberglarse, A Q Christense, Jorge Ingerslev
    Abstract:

    Abstract Background Patients experiencing massive haemorrhage are at high risk of developing coagulopathy through loss, consumption, and dilution of coagulation factors and platelets. It has been reported that plasma Fibrinogen concentrations may reach a critical low level relatively early during bleeding, calling for replacement Fibrinogen therapy. Cryoprecipitate has been widely used in the past, but more recently, a pasteurized Fibrinogen Concentrate has become available. We audited the effects of Fibrinogen Concentrate therapy on laboratory and clinical outcome in patients with massive haemorrhage. Methods We identified 43 patients over the previous 2 yr to whom a Fibrinogen Concentrate had been administered as treatment for hypoFibrinogenaemia during serious haemorrhage. Platelet count, P-Fibrinogen, activated partial thromboplastin time (APTT), prothrombin time (PT), D-dimer, and volume of blood lost were obtained from medical and laboratory records. Numbers of units of red blood cells (RBC), fresh frozen plasma (FFP), and pooled platelet Concentrates were recorded before and after Fibrinogen substitution. Results A significant increase in plasma Fibrinogen concentration was observed after Fibrinogen Concentrate therapy. Platelet counts and fibrin D-dimer values remained unchanged, whereas the APTT and PT improved significantly. Requirements for RBC, FFP, and platelets were significantly reduced. Blood loss decreased significantly. Conclusions Off-label substitution therapy with a Fibrinogen Concentrate generally improved global laboratory coagulation results and as supplementary intervention, appeared to diminish the requirements for RBC, FFP, and platelet substitution in this patient cohort.

Niels Rahemeye - One of the best experts on this subject based on the ideXlab platform.

  • randomized evaluation of Fibrinogen vs placebo in complex cardiovascular surgery replace a double blind phase iii study of haemostatic therapy
    BJA: British Journal of Anaesthesia, 2016
    Co-Authors: Niels Rahemeye, Jerrold H Levy, Dirk S Schmid, Yutaka Okita, C D Maze, Alexey Schramko, A A Klei, Radim A, Yuichi Ueda, R Ranganath
    Abstract:

    Abstract Background Single-dose human Fibrinogen Concentrate (FCH) might have haemostatic benefits in complex cardiovascular surgery. Methods Patients undergoing elective aortic surgery requiring cardiopulmonary bypass were randomly assigned to receive FCH or placebo. Study medication was administered to patients with a 5 min bleeding mass of 60–250 g after separation from bypass and surgical haemostasis. A standardized algorithm for allogeneic blood product transfusion was followed if bleeding continued after study medication. Results 519 patients from 34 centres were randomized, of whom 152 (29%) met inclusion criteria for study medication. Median (IQR) pretreatment 5 min bleeding mass was 107 (76–138) and 91 (71–112) g in the FCH and placebo groups, respectively ( P =0.13). More allogeneic blood product units were administered during the first 24 h after FCH, 5.0 (2.0–11.0), when compared with placebo, 3.0 (0.0–7.0), P =0.026. Fewer patients avoided transfusion in the FCH group (15.4%) compared with placebo (28.4%), P =0.047. The FCH immediately increased plasma Fibrinogen concentration and fibrin-based clot strength. Adverse event rates were comparable in each group. Conclusions Human Fibrinogen Concentrate was associated with increased allogeneic blood product transfusion, an unexpected finding contrary to previous studies. Human Fibrinogen Concentrate may not be effective in this setting when administered according to 5-minute bleeding mass. Low bleeding rates and normal-range plasma Fibrinogen concentrations before study medication, and variability in adherence to the complex transfusion algorithm, may have contributed to these results. Clinical trial registration ClinicalTrials.gov identifier no. NCT01475669; EudraCT trial no. 2011-002685-20.

  • randomized double blinded placebo controlled trial of Fibrinogen Concentrate supplementation after complex cardiac surgery
    Journal of the American Heart Association, 2015
    Co-Authors: Marco Ranucci, Niels Rahemeye, Ekaterina Aryshnikova, Giulia Beatrice Crapelli, Lorenzo Menicanti, Alessandro Frigiola
    Abstract:

    Background Postoperative bleeding after heart operations is still a common finding, leading to allogeneic blood products transfusion. Fibrinogen and coagulation factors deficiency are possible determinants of bleeding. The experimental hypothesis of this study is that a first‐line Fibrinogen supplementation avoids the need for fresh frozen plasma (FFP) and reduces the need for any kind of transfusions. Methods and Results This was a single‐center, prospective, randomized, placebo‐controlled, double‐blinded study. One‐hundred sixteen patients undergoing heart surgery with an expected cardiopulmonary bypass duration >90 minutes were admitted to the study. Patients in the treatment arm received Fibrinogen Concentrate after protamine administration; patients in the control arm received saline solution. In case of ongoing bleeding, patients in the treatment arm could receive prothrombin complex Concentrates (PCCs) and those in the control arm saline solution. The primary endpoint was avoidance of any allogeneic blood product. Patients in the treatment arm had a significantly lower rate of any allogeneic blood products transfusion (odds ratio, 0.40; 95% confidence interval, 0.19 to 0.84, P =0.015). The total amount of packed red cells and FFP units transfused was significantly lower in the treatment arm. Postoperative bleeding was significantly ( P =0.042) less in the treatment arm (median, 300 mL; interquartile range, 200 to 400 mL) than in the control arm (median, 355 mL; interquartile range, 250 to 600 mL). Conclusions Fibrinogen Concentrate limits postoperative bleeding after complex heart surgery, leading to a significant reduction in allogeneic blood products transfusions. No safety issues were raised. Clinical Trial Registration URL: . Unique identifier: [NCT01471730][1]. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT01471730&atom=%2Fahaoa%2F4%2F6%2Fe002066.atom

  • effects of Fibrinogen Concentrate as first line therapy during major aortic replacement surgery a randomized placebo controlled trial
    Anesthesiology, 2013
    Co-Authors: Niels Rahemeye, Enny Sorense, Cristina Solomo, Christia Hagl, Dirk S Schmid, Dietrich Knoerze, Gerald Hochleitne, Alexander A Hanke, Maximilia Pichlmaie
    Abstract:

    BACKGROUND Fibrinogen is suggested to play an important role in managing major bleeding. However, clinical evidence regarding the effect of Fibrinogen Concentrate (derived from human plasma) on transfusion is limited. The authors assessed whether Fibrinogen Concentrate can reduce blood transfusion when given as intraoperative, targeted, first-line hemostatic therapy in bleeding patients undergoing aortic replacement surgery. METHODS In this single-center, prospective, placebo-controlled, double-blind study, patients aged 18 yr or older undergoing elective thoracic or thoracoabdominal aortic replacement surgery involving cardiopulmonary bypass were randomized to Fibrinogen Concentrate or placebo, administered intraoperatively. Study medication was given if patients had clinically relevant coagulopathic bleeding immediately after removal from cardiopulmonary bypass and completion of surgical hemostasis. Dosing was individualized using the fibrin-based thromboelastometry test. If bleeding continued, a standardized transfusion protocol was followed. RESULTS Twenty-nine patients in the Fibrinogen Concentrate group and 32 patients in the placebo group were eligible for the efficacy analysis. During the first 24 h after the administration of study medication, patients in the Fibrinogen Concentrate group received fewer allogeneic blood components than did patients in the placebo group (median, 2 vs. 13 U; P < 0.001; primary endpoint). Total avoidance of transfusion was achieved in 13 (45%) of 29 patients in the Fibrinogen Concentrate group, whereas 32 (100%) of 32 patients in the placebo group received transfusion (P < 0.001). There was no observed safety concern with using Fibrinogen Concentrate during aortic surgery. CONCLUSIONS Hemostatic therapy with Fibrinogen Concentrate in patients undergoing aortic surgery significantly reduced the transfusion of allogeneic blood products. Larger multicenter studies are necessary to confirm the role of Fibrinogen Concentrate in the management of perioperative bleeding in patients with life-threatening coagulopathy.

  • recovery of Fibrinogen after administration of Fibrinogen Concentrate to patients with severe bleeding after cardiopulmonary bypass surgery
    BJA: British Journal of Anaesthesia, 2010
    Co-Authors: Cristina Solomo, U Pichlmaie, H Schoechl, Christia Hagl, K Raymondos, Dirk Scheiniche, Wolfgang Koppe, Niels Rahemeye
    Abstract:

    Background. Normalization of plasma Fibrinogen levels may be associated with satisfactory haemostasis and reduced bleeding. The aim of this retrospective study was to assess Fibrinogen recovery parameters after administration of Fibrinogen Concentrate (Haemocomplettan w P) to patients with diffuse bleeding in cardiovascular surgery. Data on transfusion and patient outcomes were also collected. Methods. Patient characteristic and clinical data were obtained from patient records. Results of the thromboelastometry (FIBTEM w ) and of the standard coagulation tests, including plasma Fibrinogen level, measured before surgery, before and after haemostatic therapy, and on the following day, were retrieved from laboratory records. Results. Thirty-nine patients receiving Fibrinogen Concentrate for diffuse bleeding requiring haemostatic therapy after cardiopulmonary bypass were identified. The mean Fibrinogen Concentrate dose administered was 6.5 g. The mean Fibrinogen level increased from 1.9 to 3.6 g litre 21 (mean increment of 0.28 g litre 21 per gram of Concentrate administered); maximum clot firmness increased from 10 to 21 mm. The mean Fibrinogen increase was 2.29 (SD 0.7) mg dl 21 per mg kg 21 bodyweight of Concentrate administered. Thirty-five patients received no transfusion of fresh-frozen plasma (FFP) or platelet Concentrate after receiving Fibrinogen Concentrate; the remaining four patients received platelet Concentrate intraoperatively. Eleven patients received platelets, FFP, or both during the first postoperative day. No venous thromboses, arterial ischaemic events, or deaths were registered during hospitalization. Conclusions. In this retrospective study, Fibrinogen Concentrate was effective in increasing plasma Fibrinogen level, and contributed to the correction of bleeding after cardiovascular surgery. Br J Anaesth 2010; 104: 555‐62

  • thromboelastometry guided administration of Fibrinogen Concentrate for the treatment of excessive intraoperative bleeding in thoracoabdominal aortic aneurysm surgery
    The Journal of Thoracic and Cardiovascular Surgery, 2009
    Co-Authors: Niels Rahemeye, Cristina Solomo, Kenichi A Tanaka, M Winterhalte, S Piepenbrock, Axel Haverich, Maximilia Pichlmaie
    Abstract:

    Objective Thoracoabdominal aortic aneurysm operations are associated with extensive blood loss and high requirements for allogeneic blood product transfusion. We assessed the efficacy of intraoperative post–cardiopulmonary bypass administration of Fibrinogen Concentrate in elective thoracoabdominal aortic aneurysm surgery. Methods In a retrospective group (group A, n=12) of patients undergoing elective thoracoabdominal aortic aneurysm surgery, clinically relevant diffuse bleeding after weaning from cardiopulmonary bypass was treated with allogeneic blood products (platelet Concentrates, followed by fresh frozen plasma) according to a predetermined algorithm. In a prospective group (group F, n=6) a first therapy step with Fibrinogen Concentrate was added to the algorithm. The dose of Fibrinogen Concentrate was estimated by using thromboelastometric data (ROTEM FIBTEM). Before each step of hemostatic therapy, blood loss in the range of 60 to 250 g per 5 minutes was confirmed. Results In group F, administration of 7.8 ± 2.7 g of Fibrinogen Concentrate established hemostasis, completely avoiding intraoperative transfusion of fresh frozen plasma and platelet Concentrates. Transfusion of blood products after cardiopulmonary bypass and during the 24 hours after surgical intervention was markedly lower in group F than in group A (2.5 vs 16.4 units; 4/6 patients in group F required no transfusion of blood products), as was 24-hour drainage volume (449 vs 1092 mL). Fibrinogen plasma levels, standard coagulation parameters, and hemoglobin and hematocrit values were comparable between the 2 groups on the first postoperative day. Conclusions FIBTEM-guided post–cardiopulmonary bypass administration of Fibrinogen Concentrate resulted in improved intraoperative management of coagulopathic bleeding in thoracoabdominal aortic aneurysm operations and reduced transfusion and 24-hour drainage volume.

Herbert Schochl - One of the best experts on this subject based on the ideXlab platform.

  • theoretical modelling of Fibrinogen supplementation with therapeutic plasma cryoprecipitate or Fibrinogen Concentrate
    BJA: British Journal of Anaesthesia, 2014
    Co-Authors: Peter Collins, Gerald Hochleitner, Herbert Schochl, Cristina Solomon, K Sutor, D Crispin, S Rizoli, Marco Ranucci
    Abstract:

    Background We aimed to create a theoretical tool to model the effect of three haemostatic agents containing Fibrinogen (therapeutic plasma, cryoprecipitate, and Fibrinogen Concentrate) on the patient's plasma Fibrinogen level. Methods A mathematical model was developed step-wise. The relationship between the amount of haemostatic agent and plasma Fibrinogen level was plotted for each agent. A Fibrinogen concentration simulator (FCSamount) was developed, where the amount of haemostatic agent was calculated from patient characteristics, agent characteristics, and target plasma Fibrinogen level. Refinements were introduced so that (i) FCSamount would account for in vivo Fibrinogen recovery, (ii) circulatory volume would not increase ad infinitum with increasing amounts, and (iii) red blood cells would be included in the simulation if haematocrit decreased below a certain level. A second FCS (FCSlevel) was created to calculate Fibrinogen levels resulting from specified amounts of haemostatic agents. Results Fibrinogen concentration in haemostatic agents has a critical impact on their ability to increase patients' Fibrinogen levels. If the target plasma Fibrinogen level approaches the concentration of the Fibrinogen source, the required amounts increase exponentially; it is impossible to achieve a target above the concentration of the Fibrinogen source. Conclusions We successfully developed two theoretical tools answering the questions: ‘How much therapeutic plasma, cryoprecipitate, or Fibrinogen Concentrate would be needed to achieve a specified target Fibrinogen level?' and ‘What would be the resultant Fibrinogen level for a specified amount of haemostatic agent?' The current tools are not intended for clinical application, but they are potentially useful for educational purposes.

  • recovery of Fibrinogen Concentrate after intraosseous application is equivalent to the intravenous route in a porcine model of hemodilution
    Journal of Trauma-injury Infection and Critical Care, 2014
    Co-Authors: Christoph J Schlimp, Cristina Solomon, Claudia Keibl, Johannes Zipperle, Sylvia Nurnberger, Wolfgang Ohlinger, Heinz Redl, Herbert Schochl
    Abstract:

    BACKGROUND Fibrinogen Concentrate is increasingly considered as a hemostatic agent for trauma patients experiencing bleeding. Placing a venous access is sometimes challenging during severe hemorrhage. Intraosseous access may be considered instead. Studies of intraosseous infusion of coagulation factor Concentrates are limited. We investigated in vivo recovery following intraosseous administration of Fibrinogen Concentrate and compared the results with intravenous administration. METHODS This study was performed on 12 pigs (mean [SD] body weight, 34.1 [2.8] kg). Following controlled blood loss (35 mL/kg) and fluid replacement with balanced crystalloid solution, intraosseous (n = 6) administration of Fibrinogen Concentrate (80 mg per kilogram of bodyweight) in the proximal tibia was compared with intravenous (n = 6) administration of the same dose (Fibrinogen infusion time approximately 5 minutes in both groups). The following laboratory parameters were assessed: blood cell count, prothrombin time index, activated partial thromboplastin time, and plasma Fibrinogen concentration (Clauss assay). Coagulation status was also assessed by thromboelastometry. RESULTS All tested laboratory parameters were comparable between the intraosseous and intravenous groups at baseline, hemodilution, and 30 minutes after Fibrinogen Concentrate administration. In vivo recovery of Fibrinogen was also similar in the two groups (89% [23%] and 91% [22%], respectively). There were no significant between-group differences in any of the thromboelastometric parameters. Histologic examination indicated no adverse effects on the tissue surrounding the intraosseous administration site. CONCLUSION This study suggests that intraosseous administration of Fibrinogen Concentrate results in a recovery of Fibrinogen similar to that of intravenous administration. The intraosseous route of Fibrinogen Concentrate could be a valuable alternative in situations where intravenous access is not feasible or would be time consuming. LEVEL OF EVIDENCE Prospective, randomized, therapeutic feasibility study in an animal model, level V.

  • impact of Fibrinogen Concentrate alone or with prothrombin complex Concentrate fresh frozen plasma on plasma Fibrinogen level and fibrin based clot strength fibtem in major trauma a retrospective study
    Scandinavian Journal of Trauma Resuscitation and Emergency Medicine, 2013
    Co-Authors: Christoph J Schlimp, Marc Maegele, Wolfgang G Voelckel, Kenji Inaba, Herbert Schochl
    Abstract:

    Background Low plasma Fibrinogen concentration is a predictor of poor outcome in major trauma patients. The role of Fibrinogen Concentrate for rapidly increasing Fibrinogen plasma levels in severe trauma is not well defined.

  • a comparison of Fibrinogen measurement methods with fibrin clot elasticity assessed by thromboelastometry before and after administration of Fibrinogen Concentrate in cardiac surgery patients
    Transfusion, 2011
    Co-Authors: Cristina Solomon, Gerald Hochleitner, Herbert Schochl, Benny Sorensen, Janne Cadamuro, Bernhard Ziegler, Michael Varvenne, Niels Rahemeyer
    Abstract:

    BACKGROUND: Fibrinogen Concentrate administration can be guided by measuring Fibrinogen concentration or quality of the fibrin-based clot. This study compared different Fibrinogen concentration measurement methods with maximum clot firmness (MCF) of the fibrin clot, assessed by thromboelastometry (FIBTEM), in 33 cardiovascular surgery patients receiving Fibrinogen Concentrate for hemostatic therapy. STUDY DESIGN AND METHODS: Blood samples were collected after cardiopulmonary bypass (CPB) and after Fibrinogen Concentrate administration. FIBTEM MCF was measured using a rotational thromboelastometry device (ROTEM, Tem International). Fibrinogen concentration was measured using photo-optical (CA-7000, Siemens Healthcare Diagnostics), mechanical (KC-10 steel ball, Schnitger and Gross hook, Amelung GmbH), and electromechanical (STA-R, Diagnostica Stago) coagulometers. Assessments included agreement between Fibrinogen concentration measurements and correlations between Fibrinogen concentration and FIBTEM MCF. RESULTS: After CPB, correlations were significant (p < 0.001) between FIBTEM MCF and Fibrinogen concentration determined by steel ball (r = 0.71), hook (r = 0.73), STA-R (r = 0.81), and CA-7000 (r = 0.82) coagulometers. After Fibrinogen Concentrate administration, agreement between Fibrinogen measurement methods was severely impaired, and correlations with FIBTEM MCF were 0.39 (steel ball), 0.33 (hook), 0.59 (STA-R), and 0.33 (CA-7000). CONCLUSION: Agreement between Fibrinogen concentration measurement methods decreased considerably after Fibrinogen Concentrate administration. All methods correlated acceptably with FIBTEM MCF at the end of CPB, but not after hemostatic therapy. Further investigation is needed to explain these findings.

  • transfusion in trauma thromboelastometry guided coagulation factor Concentrate based therapy versus standard fresh frozen plasma based therapy
    Critical Care, 2011
    Co-Authors: Herbert Schochl, Gerald Hochleitner, Florian Primavesi, Beatrice Steitz, Ulrike Nienaber, Christian Arndt, Marc Maegele, Wolfgang G Voelckel, Alexander A Hanke, Cristina Solomon
    Abstract:

    Introduction Thromboelastometry (TEM)-guided haemostatic therapy with Fibrinogen Concentrate and prothrombin complex Concentrate (PCC) in trauma patients may reduce the need for transfusion of red blood cells (RBC) or platelet Concentrate, compared with fresh frozen plasma (FFP)-based haemostatic therapy.

Jeannie Callum - One of the best experts on this subject based on the ideXlab platform.

  • which is the preferred blood product for Fibrinogen replacement in the bleeding patient with acquired hypoFibrinogenemia cryoprecipitate or Fibrinogen Concentrate
    Transfusion, 2020
    Co-Authors: Melissa M Cushing, Jeannie Callum, Keyvan Karkouti, Thorsten Haas
    Abstract:

    The importance of the targeted treatment of acquired hypoFibrinogenemia during hemorrhage with a Concentrated Fibrinogen product (either cryoprecipitate or Fibrinogen Concentrate) cannot be underestimated. Fibrinogen Concentrate is a pathogen inactivated, pooled product that offers a highly purified single factor Concentrate. Cryoprecipitate is a pooled product that comes with a spectrum of other coagulation factors which may further enhance (additional procoagulant effect) or even disturb (prothrombotic risk) hemostasis. The pros and cons of each product are discussed.

  • effect of Fibrinogen Concentrate vs cryoprecipitate on blood component transfusion after cardiac surgery the fibres randomized clinical trial
    JAMA, 2019
    Co-Authors: Jeannie Callum, Michael E Farkouh, Damon C Scales, Nancy M Heddle, Mark Crowther, Vivek Rao
    Abstract:

    Importance Excessive bleeding is a common complication of cardiac surgery. An important cause of bleeding is acquired hypoFibrinogenemia (Fibrinogen level Objective To determine if Fibrinogen Concentrate is noninferior to cryoprecipitate for treatment of bleeding related to hypoFibrinogenemia after cardiac surgery. Design, Setting, and Participants Randomized clinical trial at 11 Canadian hospitals enrolling adult patients experiencing clinically significant bleeding and hypoFibrinogenemia after cardiac surgery (from February 10, 2017, to November 1, 2018). Final 28-day follow-up visit was completed on November 28, 2018. Interventions Fibrinogen Concentrate (4 g; n = 415) or cryoprecipitate (10 units; n = 412) for each ordered dose within 24 hours after cardiopulmonary bypass. Main Outcomes and Measures Primary outcome was blood components (red blood cells, platelets, plasma) administered during 24 hours post bypass. A 2-sample, 1-sided test for the ratio of the mean number of units was conducted to evaluate noninferiority (threshold for noninferiority ratio, Results Of 827 randomized patients, 735 (372 Fibrinogen Concentrate, 363 cryoprecipitate) were treated and included in the primary analysis (median age, 64 [interquartile range, 53-72] years; 30% women; 72% underwent complex operations; 95% moderate to severe bleeding; and pretreatment Fibrinogen level, 1.6 [interquartile range, 1.3-1.9] g/L). The trial met the a priori stopping criterion for noninferiority at the interim analysis after 827 of planned 1200 patients were randomized. Mean 24-hour postbypass allogeneic transfusions were 16.3 (95% CI, 14.9 to 17.8) units in the Fibrinogen Concentrate group and 17.0 (95% CI, 15.6 to 18.6) units in the cryoprecipitate group (ratio, 0.96 [1-sided 97.5% CI, −∞ to 1.09;P  Conclusions and Relevance In patients undergoing cardiac surgery who develop clinically significant bleeding and hypoFibrinogenemia after cardiopulmonary bypass, Fibrinogen Concentrate is noninferior to cryoprecipitate with regard to number of blood components transfused in a 24-hour period post bypass. Use of Fibrinogen Concentrate may be considered for management of bleeding in patients with acquired hypoFibrinogenemia in cardiac surgery. Trial Registration ClinicalTrials.gov Identifier:NCT03037424

  • protocol for a phase iii non inferiority randomised comparison of a new Fibrinogen Concentrate versus cryoprecipitate for treating acquired hypoFibrinogenaemia in bleeding cardiac surgical patients the fibres trial
    BMJ Open, 2018
    Co-Authors: Jeannie Callum, Michael E Farkouh, Nancy M Heddle, Mark Crowther, Vivek Rao, Keyvan Karkouti, Damon C Scales
    Abstract:

    Introduction Coagulopathic bleeding is a serious complication of cardiac surgery to which an important contributor is acquired hypoFibrinogenaemia (plasma Fibrinogen Methods and analysis Fibrinogen REplenishment in Surgery (FIBRES) is a multicentre, randomised (1:1), active-control, single-blinded, phase III trial in adult cardiac surgical patients experiencing clinically significant bleeding related to acquired hypoFibrinogenaemia. The primary objective is to demonstrate that Fibrinogen Concentrate (Octafibrin/Fibryga; Octapharma) is non-inferior to cryoprecipitate. All patients for whom Fibrinogen supplementation is ordered by the clinical team within 24 hours of cardiopulmonary bypass will receive 4 g of Fibrinogen Concentrate or 10 units of cryoprecipitate (dose-equivalent to 4 g), based on random allocation and deferred consent. The primary outcome is total red cell, platelet and plasma transfusions administered within 24 hours of bypass. Secondary outcomes include major bleeding, Fibrinogen levels and adverse events within 28 days. Enrolment of 1200 patients will provide >90% power to demonstrate non-inferiority. One preplanned interim analysis will include 600 patients. The pragmatic design and treatment algorithm align with standard practice, aiding adherence and generalisability. Ethics and dissemination The study is approved by the local research ethics board and will be conducted in accordance with the Declaration of Helsinki, Good Clinical Practice guidelines and regulatory requirements. Patient consent prior to treatment is waived, as per criteria in the Tri-Council Policy Statement. Results will be published in the scientific/medical literature, and at international congresses. Non-inferiority of purified Fibrinogen Concentrate would support its use in acquired hypoFibrinogenaemia. The results are likely to improve care for cardiac surgical patients experiencing significant bleeding, an understudied yet high-risk population. Trial registration number NCT03037424; Pre-results.