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Martin Wullschleger - One of the best experts on this subject based on the ideXlab platform.
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targeted Cryoprecipitate transfusion in severe traumatic haemorrhage
Injury-international Journal of The Care of The Injured, 2020Co-Authors: Erick Chan, Don Campbell, Elizabeth Wake, Kerin Walters, Andrew C Bulmer, James Mccullough, Martin WullschlegerAbstract:Background: Severe traumatic haemorrhage is the leading cause of death in young adults. Trauma Induced Coagulopathy is a complex and multifactorial phenomenon associated with severe traumatic haemorrhage. Fibrinogen is one of the first coagulation factors to become depleted in TIC and evidence suggests that severely injured trauma patients with hypofibrinogenaemia have poor outcomes. It is postulated that early fibrinogen replacement can improve clinical outcomes. This study investigated Cryoprecipitate transfusion in hyopfibrinogeneamic trauma patients. Methods: This retrospective, single center, observational study investigated the use of Cryoprecipitate in severely injured trauma patients admitted to an Australian Level I Trauma Centre. The primary outcome was time to administration of Cryoprecipitate after identification of hypofibrinogenaemia using ROTEM (FIBTEM A5). Data collected included demographics, ISS, laboratory values of coagulation and blood product usage. Results: 71 patients received Cryoprecipitate with a median time of 61 minutes [IQR 37-93] from FIBTEM A5 result to initial Cryoprecipitate administration. At 24 hours following admission to ED, Clauss Fibrinogen levels increased by 1.30g/L [IQR 0.45-1.85] and FIBTEM A5 assay increased by 8mm [IQR 3.0-11.3]. Changes in both variables were highly significant (p<0.001) and Clauss Fibrinogen versus FIBTEM A5 values showed moderate to strong correlation (R=0.75-0.80). Conclusion: This study demonstrated that early administration of Cryoprecipitate was both feasible and efficacious in fibrinogen replacement in severe traumatic haemorrhage. High-level evidence supporting Cryoprecipitate or fibrinogen concentrate replacement with regards to efficacy and feasibility is required to guide future clinical practice. This study provided baseline data to inform the design of further clinical trials investigating fibrinogen replacement in traumatic haemorrhage.
William P Sheffield - One of the best experts on this subject based on the ideXlab platform.
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bacteria can proliferate in thawed Cryoprecipitate stored at room temperature for longer than 4 h
Vox Sanguinis, 2017Co-Authors: Sandra Ramirezarcos, William P Sheffield, Craig JenkinsAbstract:Although key coagulation factor activities are maintained in thawed Cryoprecipitate stored for up to 24 h at ambient temperature, several jurisdictions limit such storage to 4-6 h. Here, we separately spiked thawed Cryoprecipitate units with four bacterial strains: Staphylococcus epidermidis, Serratia liquefaciens, Pseudomonas putida and Pseudomonas aeruginosa. No strains grew in the first 4 h of storage, but by 24 h, three of four exhibited up to 1000-fold proliferation. Pathogen inactivation technologies could be explored to mitigate the safety risk posed by extending storage of thawed Cryoprecipitate at room temperature.
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stability of coagulation protein activities in single units or pools of Cryoprecipitate during storage at 20 24 c for up to 24 h
Vox Sanguinis, 2016Co-Authors: William P Sheffield, Varsha Bhakta, Craig JenkinsAbstract:Background and Objective Cryoprecipitate is a concentrated source of fibrinogen and other plasma proteins. Cryoprecipitate must be transfused within 4–6 h of thawing and storage at 20–24°C. We compared plasma protein activities in single or pooled Cryoprecipitate units stored at 20–24°C for 0, 4 or 24 h. Materials and Methods Individual Cryoprecipitate units (n = 36) were thawed, diluted with sterile saline and sampled over time. Cryoprecipitate pools of eight individual units were assembled either by serial passage of diluent (Method A, n = 6 pools) or by separate dilution into a single collection bag (Method B, n = 6 pools). Fibrinogen, factor VIII, factor XIII and von Willebrand factor activities were measured. Results No significant losses in activities were found relative to at-thaw values after either 4 or 24 h of storage of individual Cryoprecipitate units at 20–24°C; 35 of 36 units contained >150 mg of fibrinogen. No significant differences were found between activities in single vs. pooled units of Cryoprecipitate assembled using either method, or between Cryoprecipitate pools made by Method A (80–160 ml volume) or Method B (160–240 ml volume) at 0, 4 or 24 h post-thaw; freezing and thawing of pools did not lead to significant activity losses. Conclusion The stability of fibrinogen and other factors in thawed Cryoprecipitate stored at 20–24°C suggests that the shelf life may be safely extended to 24 h provided that sterility is maintained.
Erick Chan - One of the best experts on this subject based on the ideXlab platform.
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targeted Cryoprecipitate transfusion in severe traumatic haemorrhage
Injury-international Journal of The Care of The Injured, 2020Co-Authors: Erick Chan, Don Campbell, Elizabeth Wake, Kerin Walters, Andrew C Bulmer, James Mccullough, Martin WullschlegerAbstract:Background: Severe traumatic haemorrhage is the leading cause of death in young adults. Trauma Induced Coagulopathy is a complex and multifactorial phenomenon associated with severe traumatic haemorrhage. Fibrinogen is one of the first coagulation factors to become depleted in TIC and evidence suggests that severely injured trauma patients with hypofibrinogenaemia have poor outcomes. It is postulated that early fibrinogen replacement can improve clinical outcomes. This study investigated Cryoprecipitate transfusion in hyopfibrinogeneamic trauma patients. Methods: This retrospective, single center, observational study investigated the use of Cryoprecipitate in severely injured trauma patients admitted to an Australian Level I Trauma Centre. The primary outcome was time to administration of Cryoprecipitate after identification of hypofibrinogenaemia using ROTEM (FIBTEM A5). Data collected included demographics, ISS, laboratory values of coagulation and blood product usage. Results: 71 patients received Cryoprecipitate with a median time of 61 minutes [IQR 37-93] from FIBTEM A5 result to initial Cryoprecipitate administration. At 24 hours following admission to ED, Clauss Fibrinogen levels increased by 1.30g/L [IQR 0.45-1.85] and FIBTEM A5 assay increased by 8mm [IQR 3.0-11.3]. Changes in both variables were highly significant (p<0.001) and Clauss Fibrinogen versus FIBTEM A5 values showed moderate to strong correlation (R=0.75-0.80). Conclusion: This study demonstrated that early administration of Cryoprecipitate was both feasible and efficacious in fibrinogen replacement in severe traumatic haemorrhage. High-level evidence supporting Cryoprecipitate or fibrinogen concentrate replacement with regards to efficacy and feasibility is required to guide future clinical practice. This study provided baseline data to inform the design of further clinical trials investigating fibrinogen replacement in traumatic haemorrhage.
Magdy Elekiaby - One of the best experts on this subject based on the ideXlab platform.
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solvent detergent filtered s d f fresh frozen plasma and Cryoprecipitate minipools prepared in a newly designed integral disposable processing bag system
Transfusion Medicine, 2010Co-Authors: Magdy Elekiaby, C Caron, Miryana Radosevich, Hadi Goubran, J Goudemand, Mohsen Sayed, S Burnouf, N Elsharkawy, David BlumAbstract:: Solvent-detergent (S/D) viral inactivation was recently adapted to the treatment of single plasma donations and Cryoprecipitate minipools. We present here a new process and a new bag system where the S/D reagents are removed by filtration and the final products subjected to bacterial (0.2 microm) filtration. Recovered and apheresis plasma for transfusion (FFP) and Cryoprecipitate minipools (400 +/- 20 mL) were subjected to double-stage S/D viral inactivation, followed by one oil extraction and a filtration on a S/D and phthalate [di(2-ethylhexyl) phthalate (DEHP)] adsorption device and a 0.2 microm filter. The initial and the final products were compared for visual appearance, blood cell count and cell markers, proteins functional activity, von Willebrand factor (VWF) multimers and protein profile by sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE). Tri (n-butyl) phosphate (TnBP) was quantified by gas chromatography and Triton X-45 and DEHP by high-performance-liquid chromatography (HPLC). General safety tests were by 6.5 mL/kg intravenous injection in rats. The treated plasmas and Cryoprecipitates were very clear and the protein content and functionality, VWF multimers and SDS-PAGE profiles were well preserved. TnBP and Triton X-45 were < 1 and <25 ppm, respectively, and DEHP (about 5 ppm) was less than it was in the starting materials. Blood cell counts and CD45, CD61 and glycophorin A markers were negative. There was no enhanced toxicity in rats. Thus, plasma and Cryoprecipitate can be S/D-treated in this new CE-marked disposable integral processing system under conditions preserving protein function and integrity, removing blood cells, S/D agents and DEHP, and ensuring bacterial sterility. This process may offer one additional option to blood establishments for the production of virally inactivated plasma components.
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properties of a concentrated minipool solvent detergent treated Cryoprecipitate processed in single use bag systems
Haemophilia, 2008Co-Authors: Thierry Burnouf, C Caron, Miryana Radosevich, Hadi Goubran, J Goudemand, Magdy ElekiabyAbstract:Cryoprecipitate is still used to treat factor VIII (FVIII), von Willebrand factor (VWF) and/or fibrinogen deficiency. Recently a solvent-detergent (S/D) process of minipools of Cryoprecipitate performed in a closed bag system has been designed to improve its viral safety. Still, Cryoprecipitate has other drawbacks, including low concentration in active proteins, and presence of haemolytic isoagglutinins. We report here the biochemical evaluation of S/D-treated minipools of Cryoprecipitates depleted of cryo-poor plasma. Cryoprecipitates were solubilized by 8 mL of a sterile glucose/saline solution, pooled in batches of 40 donations and subjected to S/D treatment in a plastic bag system using either 2% TnBP or 1% TnBP-1%Triton X-45, followed by oil extractions (n = 10). Mean (+/-SD) FVIII and fibrinogen content was 8.86 (+/-1.29) IU mL(-1) and 16.02 (+/-1.98) mg mL(-1), and 8.92 (+/-1.05) IU mL(-1) in Cryoprecipitate minipools treated with 2% TnBP, and 17.26 (+/-1.71) mg mL(-1), in those treated by TnBP-Triton X-45, respectively. The WWF antigen, ristocetin cofactor and collagen binding activities were close to 10, 7 and 8 IU mL(-1), respectively, and were not affected by either SD treatment. VWF multimeric pattern of SD-treated Cryoprecipitates were similar to that of normal plasma, and the >15 mers and >10 mers content was identical to that of the starting Cryoprecipitates. The anti-A and anti-B titre was 0-1 and 0-1/8, respectively. Therefore, it is possible to prepare virally inactivated Cryoprecipitate minipools depleted of isoagglutinins and enriched in functional FVIII, VWF and clottable fibrinogen.
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a minipool process for solvent detergent treatment of Cryoprecipitate at blood centres using a disposable bag system
Vox Sanguinis, 2006Co-Authors: Thierry Urnouf, Miryana Radosevich, Hadi Goubra, Mohse Sayed, G Gorgy, Magdy ElekiabyAbstract:Background and Objectives Single-donor or small-pool Cryoprecipitates are produced by blood establishments, mostly in developing countries, for substitute therapy in haemophilia A, von Willebrand disease and fibrinogen deficiency, as well as for the manufacture of fibrin sealant. As Cryoprecipitate may be contaminated with pathogenic plasma-borne viruses, there is an urgent need to develop a simple method for the viral inactivation of Cryoprecipitate. Materials and Methods Cryoprecipitate was obtained according to standard procedures. Ten minipools of five or six donations of Cryoprecipitate were prepared and subjected, in sterile closed bags, to a viral inactivation treatment using either 2% tri(n-)butyl phosphate (TnBP) for 4 h at 37 °C or the combination of 1% TnBP and 1% Triton X-45 for 4 h at 31 °C. The Cryoprecipitates were subsequently extracted three times in their processing bags by mixing and decantation using 7·5% sterile ricinus oil. The TnBP-treated Cryoprecipitates were further subjected to a clarifying centrifugation step at 3800 g for 30 min. The final products were dispensed into individual bags and frozen at −30 °C or lower. Results The Cryoprecipitates treated with either 2% TnBP or 1% TnBP + 1% Triton X-45 showed excellent (> 93%) mean recovery of coagulant factor VIII (FVIII), ristocetin cofactor Von Willebrand factor (VWF:RCo), and clottable fibrinogen activity. Prothrombin time, international normalized ratio and activated partial thromboplastin time increased during solvent–detergent treatment but returned to initial values after oil extractions. The final content of TnBP and Triton X-45 was < 10 and 50 ppm, indicating excellent removal by the oil-extraction procedure. Conclusions Viral inactivation treatment by TnBP, with or without Triton X-45, can be applied to minipools of Cryoprecipitate, with good recovery of FVIII, VWF and fibrinogen. The viral inactivation and solvent–detergent removal process can be performed in a closed bag system and using simple blood establishment techniques and equipment. This technology could be considered for the improved viral safety of Cryoprecipitate which is used to treat haemophilia A, von Willebrand disease or fibrinogen deficiency, or to prepare fibrin sealant.
Craig Jenkins - One of the best experts on this subject based on the ideXlab platform.
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bacteria can proliferate in thawed Cryoprecipitate stored at room temperature for longer than 4 h
Vox Sanguinis, 2017Co-Authors: Sandra Ramirezarcos, William P Sheffield, Craig JenkinsAbstract:Although key coagulation factor activities are maintained in thawed Cryoprecipitate stored for up to 24 h at ambient temperature, several jurisdictions limit such storage to 4-6 h. Here, we separately spiked thawed Cryoprecipitate units with four bacterial strains: Staphylococcus epidermidis, Serratia liquefaciens, Pseudomonas putida and Pseudomonas aeruginosa. No strains grew in the first 4 h of storage, but by 24 h, three of four exhibited up to 1000-fold proliferation. Pathogen inactivation technologies could be explored to mitigate the safety risk posed by extending storage of thawed Cryoprecipitate at room temperature.
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stability of coagulation protein activities in single units or pools of Cryoprecipitate during storage at 20 24 c for up to 24 h
Vox Sanguinis, 2016Co-Authors: William P Sheffield, Varsha Bhakta, Craig JenkinsAbstract:Background and Objective Cryoprecipitate is a concentrated source of fibrinogen and other plasma proteins. Cryoprecipitate must be transfused within 4–6 h of thawing and storage at 20–24°C. We compared plasma protein activities in single or pooled Cryoprecipitate units stored at 20–24°C for 0, 4 or 24 h. Materials and Methods Individual Cryoprecipitate units (n = 36) were thawed, diluted with sterile saline and sampled over time. Cryoprecipitate pools of eight individual units were assembled either by serial passage of diluent (Method A, n = 6 pools) or by separate dilution into a single collection bag (Method B, n = 6 pools). Fibrinogen, factor VIII, factor XIII and von Willebrand factor activities were measured. Results No significant losses in activities were found relative to at-thaw values after either 4 or 24 h of storage of individual Cryoprecipitate units at 20–24°C; 35 of 36 units contained >150 mg of fibrinogen. No significant differences were found between activities in single vs. pooled units of Cryoprecipitate assembled using either method, or between Cryoprecipitate pools made by Method A (80–160 ml volume) or Method B (160–240 ml volume) at 0, 4 or 24 h post-thaw; freezing and thawing of pools did not lead to significant activity losses. Conclusion The stability of fibrinogen and other factors in thawed Cryoprecipitate stored at 20–24°C suggests that the shelf life may be safely extended to 24 h provided that sterility is maintained.