Effectiveness of prothrombin complex concentrate for the treatment of bleeding: A systematic review and meta‐analysis

Brink, Daan P. van den; Wirtz, Mathijs R.; Neto, Ary Serpa; Schöchl, Herbert; Viersen, V.A.; Binnekade, Jan M.; Juffermans, Nicole P.

doi:10.1111/jth.14991

Cited by 43 publications

(34 citation statements)

References 46 publications

(171 reference statements)

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“…To date, several observational studies and a single randomized pilot study have compared the use of PCC with FP in cardiac surgery. 13 , 23 Although the observational studies are heterogeneous, meta-analyses of their results suggest that PCC is associated with decreased blood loss and red cell transfusions, 13 , 23 which is consistent with the findings of our study. The meta-analyses also explored the safety of PCC and found no association with thromboembolic adverse events, but did note a trend toward increased risk of kidney dysfunction.…”

Section: Discussionsupporting

confidence: 91%

Comparison of 4-Factor Prothrombin Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After Cardiac Surgery

et al. 2021

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Key Points Question Can 4-factor prothrombin complex concentrate (PCC) be used as a substitute for frozen plasma (FP) for treatment of bleeding related to coagulation factor deficiency in cardiac surgery? Findings In this pilot trial, 101 adult patients were successfully randomized to receive PCC or FP for bleeding during cardiac surgery. In exploratory analyses, the PCC group had significantly lower chest tube blood loss and received fewer allogeneic blood transfusions, whereas the number of thromboembolic events was similar. Meaning Four-factor PCC may be a suitable alternative to FP for management of cardiac surgery–associated coagulopathy, pending assessment by adequately powered multicenter trials.

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Section: Discussionsupporting

confidence: 91%

Comparison of 4-Factor Prothrombin Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After Cardiac Surgery

et al. 2021

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“…Pharmaceutic hemostatic agents such as fibrinogen concentrate and PCC have been widely incorporated into current therapeutic algorithms for the treatment of massive hemorrhage in trauma patients, intraoperatively, and in cases of obstetric hemorrhage [ 35 , 36 ]. Their use is widespread in many countries and numerous studies have demonstrated their clinical benefits over FFP [ 37 , 38 , 39 ]. The low rate of use of hemostatic agents recorded in our study may not reflect the true picture, since the provision of these agents may not be carried out exclusively through BTSs.…”

Section: Discussionmentioning

confidence: 99%

Current Practice in FFP Preparation and Use in Greece. A National Survey

Argyrou

Valsami

Pouliakis

et al. 2020

Tjh

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Objective: Fresh frozen plasma (FFP) transfusion is widely used in modern clinical settings. Practices regarding its use vary due to lack of guidelines from randomized trials. The aim of this study was to assess both the current practices regarding FFP production, use, and wastage and the implementation of quality control (QC), female donor plasma production policies, and use of pharmaceutical hemostatic agents in Greece. Materials and Methods: The study was conducted during February-April 2018. For the first part of the study, data including FFP transfusion indication, hospital department, diagnosis, FFP units/transfusion episode, ABO compatibility, blood donor’s sex, and reasons for discarding were collected. For the second part, questionnaire data were analyzed. Results: According to data from 20 Greek hospitals, 12655 FFP units were transfused to 2700 patients during 5069 transfusion episodes in the studied period of time. Most patients were hospitalized in internal medicine, general surgery, and intensive care unit departments. Each patient received on average 4.69 units (2.5 units/episode). Transfusion requests were in accordance with international guidelines in 63.44% of cases and 99.04% of the units were given to ABO-identical patients. Main reasons for discarding included failure to meet quality requirements (30.06%), female donors (22.17%), and other causes (27.26%). Among 96.9% of all transfusion services across the country, 28.26% perform QC according to the directions of the European Directorate for the Quality of Medicines & Health Care and 68.83% discard plasma from female donors. Pharmaceutic hemostatic agents are used in 37.23% of the hospitals. Conclusion: This is the first national survey regarding FFP production and transfusion in Greece. Staff of internal medicine, general surgery, and ICU departments, where most FFP-transfused patients are hospitalized, should be regularly involved in training on contemporary transfusion guidelines. Upcoming centralization of FFP production and inventory management could help in homogenizing practices regarding FFP use and improve product quality. Strengthening the use of pharmaceutic hemostatic agents could improve patients’ management.

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“…However, to what extent these parameters are influenced by thrombin generation or substrates such as fibrinogen or platelets remains to be elucidated. Importantly, the use of prothrombin complex concentrate in bleeding patients does not come without significant side effects and has been associated with rates of up to 41% of thromboembolic events [18].…”

Section: Introductionmentioning

confidence: 99%

Sufficient Thrombin Generation Despite 95% Hemodilution: An In Vitro Experimental Study

Gratz

Schlimp

Honickel

et al. 2020

JCM

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Guidelines for the treatment of severe bleeding comprise viscoelastic-test-guided use of coagulation factor concentrates as part of their recommendations. The aim of this study is to investigate the effects of substituting fibrinogen, prothrombin complex concentrate, and a combination of both on conventional coagulation tests, viscoelastic test results, and thrombin generation. Blood was drawn from seven healthy volunteers to obtain platelet-free plasma, which later was diluted by replacing 40%, 60%, 80%, 90%, 95%, and 99% with a crystalloid solution. The diluted samples were spiked with fibrinogen concentrate, prothrombin complex concentrate, a combination of both, or a corresponding amount of crystalloid solution. Up to a dilution level of 95%, viscoelastically determined clotting time was significantly shorter in the group substituted with fibrinogen only in comparison with the additional use of prothrombin complex concentrate. Clot firmness and endogenous thrombin potential remained at relatively stable values up to a dilution level of 95% with the substitution of fibrinogen but not prothrombin complex concentrate. Substitution of prothrombin complex concentrate led to an excessive overshoot of thrombin generation. The results of our study question currently propagated treatment algorithms for bleeding patients that include the use of prothrombin complex concentrate for patients without former intake of oral anticoagulants. Even in severely bleeding patients, thrombin generation might be sufficient to achieve adequate hemostasis.

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Effectiveness of prothrombin complex concentrate for the treatment of bleeding: A systematic review and meta‐analysis

Abstract: This is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

Cited by 43 publications

References 46 publications

Comparison of 4-Factor Prothrombin Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After Cardiac Surgery

Comparison of 4-Factor Prothrombin Complex Concentrate With Frozen Plasma for Management of Hemorrhage During and After Cardiac Surgery

Current Practice in FFP Preparation and Use in Greece. A National Survey

Sufficient Thrombin Generation Despite 95% Hemodilution: An In Vitro Experimental Study

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