Prothrombin Complex

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Jerrold H. Levy - One of the best experts on this subject based on the ideXlab platform.

  • using plasma and Prothrombin Complex concentrates
    Seminars in Thrombosis and Hemostasis, 2020
    Co-Authors: Jerrold H. Levy, Kamrouz Ghadimi, Nathan H Waldron, Jean M Connors
    Abstract:

    Surgical patients, following procedural interventions or traumatic injury, often bleed due to ongoing blood loss or coagulopathy. Volume resuscitation and transfusion management are critical for the massively bleeding patient. While transfusions may correct coagulopathy, they carry multiple risks including circulatory overload and transfusion-related acute lung injury. Factor concentrates, specifically Prothrombin Complex concentrates (PCCs), are often used as part of multimodal therapy for bleeding along with laboratory testing to rapidly assess underlying coagulopathy. Although they are commonly used as part of management algorithms, studies evaluating their efficacy against fresh frozen plasma (FFP) or other potential therapies are needed. Further, PCCs are indicated to treat the coagulopathy associated with non-vitamin K oral anticoagulants in the perioperative setting. The focus of this commentary will be the perioperative use of PCCs, plasma, and FFP.

  • Prothrombin Complex Concentrates for Perioperative Vitamin K Antagonist and Non-vitamin K Anticoagulant Reversal.
    Anesthesiology, 2018
    Co-Authors: Jerrold H. Levy, James D. Douketis, Thorsten Steiner, Joshua N. Goldstein, Truman J. Milling
    Abstract:

    Vitamin K antagonist therapy is associated with an increased bleeding risk, and clinicians often reverse anticoagulation in patients who require emergency surgical procedures. Current guidelines for rapid anticoagulation reversal for emergency surgery recommend four-factor Prothrombin Complex concen

  • Prothrombin Complex Concentrates in Trauma and Perioperative Bleeding
    Anesthesiology, 2015
    Co-Authors: Oliver Grottke, Jerrold H. Levy
    Abstract:

    Abstract There is increasing interest in Prothrombin Complex concentrates as therapy for perioperative and trauma-related bleeding. A suitable point-of-care test is needed to guide such therapy, and randomized controlled trials are needed for robust, evidence-based recommendations.

C Dempfle - One of the best experts on this subject based on the ideXlab platform.

  • Reversal of oral anticoagulation with Prothrombin Complex concentrate (Octaplex)
    Critical Care, 2007
    Co-Authors: Hanno Riess, A Meier-hellmann, J Motsch, Elias M, C Dempfle
    Abstract:

    Oral anticoagulant therapy with vitamin K antagonists may need to be rapidly reversed if acute bleeding occurs or surgical intervention is required. This can most effectively be achieved by administering Prothrombin Complex concentrates (PCCs), which correct the INR more quickly than fresh frozen plasma without the problem of volume overload. Octaplex, a virus-inactivated PCC containing balanced potencies of coagulation factors and the regulating proteins C and S, was developed with the intention of making a rapid contribution to coagulation whilst limiting the risk of thrombosis.

  • Prothrombin Complex concentrate octaplex in patients requiring immediate reversal of oral anticoagulation
    Thrombosis Research, 2007
    Co-Authors: Hanno Riess, J Motsch, Andreas Meierhellmann, Mazen Elias, Friedrich W Kursten, C Dempfle
    Abstract:

    Abstract Introduction Rapid reversal of anticoagulant effect from the use of vitamin K antagonists (VKA) is essential when acute bleeding or emergency surgery occurs. Prothrombin Complex concentrates (PCCs) produce a more rapid effect with a better clinical outcome, and do not cause volume overload as compared with fresh-frozen plasma (FFP). Octaplex ® is a modern, double virus safeguarded PCC with balanced content of vitamin K-dependent coagulation factors, which ensures fast onset of action and efficacious treatment, i.e. rapid correction of international normalized ratio (INR). Materials and methods The main purpose of this study was to demonstrate that Octaplex ® , when individually dosed, efficiently corrects INR to pre-determined levels in patients under oral anticoagulation who have bleeding complications or are undergoing invasive procedures. To measure the efficacy response, the INR achieved after PCC application per patient was calculated as geometric mean of three measurements within 1 h post-infusion. Results Sixty patients received a median total Octaplex ® dose of 41.1 (15.3–83.3) IU/kg body weight (bw). Of 56 patients evaluable in terms of efficacy, 51 (91%) showed a response as pre-defined in the protocol and in 52 (93%) the INR decreased to a value below 1.4 within one hour after dosing. The median INR declined from 2.8 (1.5–9.5) to 1.1 (1.0–1.9) within 10 min. All Prothrombin Complex coagulation factors recovered in parallel. Three patients had minor adverse drug reactions. One patient showed a non-symptomatic parvovirus B19 seroconversion. No thrombotic side effects were observed. Conclusions Octaplex ® is efficacious and safe in immediate correction of dosage-dependent INR in patients with VKA-related deficiency of Prothrombin Complex coagulation factors.

Gary D Peksa - One of the best experts on this subject based on the ideXlab platform.

  • Emergent Warfarin Reversal With Fixed-Dose 4-Factor Prothrombin Complex Concentrate.
    The Annals of pharmacotherapy, 2020
    Co-Authors: Brianna Jansma, Scott K Dietrich, Gary D Peksa, Josephine Montgomery, Mark Mixon, Brett Faine
    Abstract:

    Background:Four-factor Prothrombin Complex concentrate (4FPCC) is used for emergent warfarin reversal, but dosing remains controversial. Following approval, further studies have evaluated a variety...

  • Reversal of Warfarin-Associated Major Hemorrhage: Activated Prothrombin Complex Concentrate versus 4-Factor Prothrombin Complex Concentrate.
    Thrombosis and haemostasis, 2019
    Co-Authors: Gary D Peksa, Robert K Mokszycki, Megan A Rech, Brian Maynard, Nicholas G Panos, Rolla T Sweis, Joshua M Demott
    Abstract:

    Warfarin-associated major hemorrhage is frequently treated with Prothrombin Complex concentrates to correct international normalized ratio (INR).  This article aims to investigate the efficacy of activated Prothrombin Complex concentrate (aPCC) versus 4-factor Prothrombin Complex concentrate (4PCC) for vitamin K antagonist reversal in patients with warfarin-associated major hemorrhage.  This was a multicenter, retrospective cohort study. Patients included were age ≥ 18 years with pretreatment INR of > 1.5. Exclusion criteria were patients treated for urgent procedures without hemorrhage, treated but not taking warfarin, unavailable INR values, and pregnant patients. Patients were stratified into two groups: aPCC or 4PCC. The primary outcome was achievement of INR ≤ 1.5 at the posttreatment INR sampling. Secondary outcomes focused on thrombotic events and mortality.  Of 342 patients, 237 patients received aPCC and 105 patients received 4PCC. After 1:1 propensity score matching, 86 patients remained in each group. In the matched cohort, the proportion of patients who achieved target INR ≤ 1.5 was greater with 4PCC (aPCC = 61 [70.9%] vs. 4PCC = 76 [88.4%]; 95% confidence interval [CI] -29.2% to -5.7%) and groups had comparable in-hospital thrombotic events and mortality. In the unmatched cohort, achievement of target INR ≤ 1.5 was greater with 4PCC (aPCC = 151 [63.7%] vs. 4PCC = 92 [87.6%]; 95% CI -32.7% to -15.1%).  In the treatment of warfarin-associated major hemorrhage, 4PCC compared with aPCC was associated with greater achievement of INR ≤ 1.5 with comparable thrombotic events and mortality. Further controlled studies are needed to confirm these findings and determine the optimal dosing strategy that maximizes efficacy and safety. Georg Thieme Verlag KG Stuttgart · New York.

Joshua M Demott - One of the best experts on this subject based on the ideXlab platform.

  • Reversal of Warfarin-Associated Major Hemorrhage: Activated Prothrombin Complex Concentrate versus 4-Factor Prothrombin Complex Concentrate.
    Thrombosis and haemostasis, 2019
    Co-Authors: Gary D Peksa, Robert K Mokszycki, Megan A Rech, Brian Maynard, Nicholas G Panos, Rolla T Sweis, Joshua M Demott
    Abstract:

    Warfarin-associated major hemorrhage is frequently treated with Prothrombin Complex concentrates to correct international normalized ratio (INR).  This article aims to investigate the efficacy of activated Prothrombin Complex concentrate (aPCC) versus 4-factor Prothrombin Complex concentrate (4PCC) for vitamin K antagonist reversal in patients with warfarin-associated major hemorrhage.  This was a multicenter, retrospective cohort study. Patients included were age ≥ 18 years with pretreatment INR of > 1.5. Exclusion criteria were patients treated for urgent procedures without hemorrhage, treated but not taking warfarin, unavailable INR values, and pregnant patients. Patients were stratified into two groups: aPCC or 4PCC. The primary outcome was achievement of INR ≤ 1.5 at the posttreatment INR sampling. Secondary outcomes focused on thrombotic events and mortality.  Of 342 patients, 237 patients received aPCC and 105 patients received 4PCC. After 1:1 propensity score matching, 86 patients remained in each group. In the matched cohort, the proportion of patients who achieved target INR ≤ 1.5 was greater with 4PCC (aPCC = 61 [70.9%] vs. 4PCC = 76 [88.4%]; 95% confidence interval [CI] -29.2% to -5.7%) and groups had comparable in-hospital thrombotic events and mortality. In the unmatched cohort, achievement of target INR ≤ 1.5 was greater with 4PCC (aPCC = 151 [63.7%] vs. 4PCC = 92 [87.6%]; 95% CI -32.7% to -15.1%).  In the treatment of warfarin-associated major hemorrhage, 4PCC compared with aPCC was associated with greater achievement of INR ≤ 1.5 with comparable thrombotic events and mortality. Further controlled studies are needed to confirm these findings and determine the optimal dosing strategy that maximizes efficacy and safety. Georg Thieme Verlag KG Stuttgart · New York.

Joshua R. Canter - One of the best experts on this subject based on the ideXlab platform.

  • Activated Prothrombin Complex Concentrate Versus 4-Factor Prothrombin Complex Concentrate for Vitamin K-Antagonist Reversal.
    Critical care medicine, 2018
    Co-Authors: A. Shaun Rowe, Scott K Dietrich, John W. Phillips, Kaci E. Foster, Joshua R. Canter
    Abstract:

    OBJECTIVES To compare the international normalized ratio normalization efficacy of activated Prothrombin Complex concentrates and 4-factor Prothrombin Complex concentrates and to evaluate the thrombotic complications in patients treated with these products for warfarin-associated hemorrhage. DESIGN Retrospective, Multicenter Cohort. SETTING Large, Community, Teaching Hospital. PATIENTS Patients greater than 18 years old and received either activated Prothrombin Complex concentrate or 4-factor Prothrombin Complex concentrate for the treatment of warfarin-associated hemorrhage. We excluded those patients who received either agent for an indication other than warfarin-associated hemorrhage, pregnant, had a baseline international normalized ratio of less than 2, received a massive transfusion as defined by hospital protocol, received plasma for treatment of warfarin-associated hemorrhage, or were treated for an acute warfarin ingestion. INTERVENTIONS Patients in the activated Prothrombin Complex concentrate group (enrolled from one hospital) with an international normalized ratio of less than 5 received 500 IU and those with an international normalized ratio greater than 5 received 1,000 IU. Patients in the 4-factor Prothrombin Complex concentrate (enrolled from a separate hospital) group received the Food and Drug Administration approved dosing algorithm. MEASUREMENTS AND MAIN RESULTS A total of 158 patients were included in the final analysis (activated Prothrombin Complex concentrate = 118; 4-factor Prothrombin Complex concentrate = 40). Those in the 4-factor Prothrombin Complex concentrate group had a higher pretreatment international normalized ratio (2.7 ± 1.8 vs 3.5 ± 2.9; p = 0.0164). However, the posttreatment international normalized ratio was similar between the groups. In addition, even when controlling for differences in the pretreatment international normalized ratio, there was no difference in the ability to achieve a posttreatment international normalized ratio of less than 1.4 (odds ratio, 0.753 [95% CI, 0.637-0.890]; p = 0.0009). Those in the activated Prothrombin Complex concentrate group did have higher odds of achieving a posttreatment international normalized ratio of less than 1.2 (odds ratio, 3.23 [95% CI, 1.34-7.81]; p = 0.0088). There was only one posttreatment thrombotic complication reported. CONCLUSIONS A low, fixed dose of activated Prothrombin Complex concentrate was as effective as standard dose 4-factor Prothrombin Complex concentrate for normalization of international normalized ratio. In addition, we did not see an increase in thrombotic events.