Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trials
Abstract Background Swift reversal of oral anticoagulation is deemed essential for the outcome of patients with anticoagulation-related critical bleeding. The aim of this systematic review was to evaluate the benefits and harms of prothrombin complex concentrate (PCC) in patients with oral anticoagu...
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2025-02-01
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| Series: | Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine |
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| Online Access: | https://doi.org/10.1186/s13049-025-01334-1 |
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| author | Christian Ovesen Jan Purrucker Josefine Grundtvig Theis Bech Mikkelsen Christian Gluud Janus Christian Jakobsen Hanne Christensen Thorsten Steiner |
| author_facet | Christian Ovesen Jan Purrucker Josefine Grundtvig Theis Bech Mikkelsen Christian Gluud Janus Christian Jakobsen Hanne Christensen Thorsten Steiner |
| author_sort | Christian Ovesen |
| collection | DOAJ |
| description | Abstract Background Swift reversal of oral anticoagulation is deemed essential for the outcome of patients with anticoagulation-related critical bleeding. The aim of this systematic review was to evaluate the benefits and harms of prothrombin complex concentrate (PCC) in patients with oral anticoagulants-related critical bleeding. Methods For this systematic review CENTRAL, MEDLINE, Embase, LILACS, BIOSIS, Web of Science, and clinical trial registries were systematically searched. Clinical study reports were also requested from competent authorities. Eligible for inclusion were randomised clinical trials comparing PCC versus no intervention, placebo, or other reversal interventions in participants with critical bleeding related to ongoing treatment with vitamin K antagonist (VKA) or direct oral anticoagulants (DOAC). Pre-specified primary outcomes were all-cause mortality, health-related quality of life, and serious adverse events for which meta-analyses, Trial Sequential Analysis, and GRADE assessments were conducted. Results Three trials, randomising a total of 291 participants, evaluated PCC against two different active comparators in participants with VKA-related critical bleeding, and two trials, randomising a total of 534 participants, evaluated PCC against two different active comparators in participants with factor Xa-related critical bleeding. Among participants with VKA-related critical bleeding, meta-analyses showed no evidence of a difference between PCC versus fresh frozen plasma (FFP) when assessing all-cause mortality (risk ratio [RR] 1.05; 95% confidence interval (CI) 0.27 to 4.05; low certainty), health-related quality of life (mean difference 1.04; 95% CI − 0.94 to 3.02; very low certainty), and serious adverse events (RR 1.33; 95% CI 0.94 to 1.88; very low certainty), but information is currently sparse. Among participants with factor Xa-related critical bleeding, PCC could not be shown superior or inferior to other reversal strategies (FFP or andexanet alfa) on any patient-relevant outcome, but information is currently sparse. Conclusion Among participants with VKA or DOAC-related critical bleeding, evidence from randomised clinical trials is currently insufficient to establish if PCC is superior or inferior versus other interventions in decreasing the risk of undesirable patient-relevant outcomes or improving health-related quality of life. |
| format | Article |
| id | doaj-art-285b21e2147f4f3da3b0819077279a1f |
| institution | Kabale University |
| issn | 1757-7241 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
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| series | Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine |
| spelling | doaj-art-285b21e2147f4f3da3b0819077279a1f2025-02-09T12:52:12ZengBMCScandinavian Journal of Trauma, Resuscitation and Emergency Medicine1757-72412025-02-0133111610.1186/s13049-025-01334-1Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trialsChristian Ovesen0Jan Purrucker1Josefine Grundtvig2Theis Bech Mikkelsen3Christian Gluud4Janus Christian Jakobsen5Hanne Christensen6Thorsten Steiner7Department of Neurology, Copenhagen University Hospital BispebjergDepartment of Neurology, Heidelberg University HospitalDepartment of Neurology, Copenhagen University Hospital BispebjergDepartment of Neurology, Copenhagen University Hospital BispebjergCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital RigshospitaletCopenhagen Trial Unit, Centre for Clinical Intervention Research, The Capital Region, Copenhagen University Hospital RigshospitaletDepartment of Neurology, Copenhagen University Hospital BispebjergDepartment of Neurology, Heidelberg University HospitalAbstract Background Swift reversal of oral anticoagulation is deemed essential for the outcome of patients with anticoagulation-related critical bleeding. The aim of this systematic review was to evaluate the benefits and harms of prothrombin complex concentrate (PCC) in patients with oral anticoagulants-related critical bleeding. Methods For this systematic review CENTRAL, MEDLINE, Embase, LILACS, BIOSIS, Web of Science, and clinical trial registries were systematically searched. Clinical study reports were also requested from competent authorities. Eligible for inclusion were randomised clinical trials comparing PCC versus no intervention, placebo, or other reversal interventions in participants with critical bleeding related to ongoing treatment with vitamin K antagonist (VKA) or direct oral anticoagulants (DOAC). Pre-specified primary outcomes were all-cause mortality, health-related quality of life, and serious adverse events for which meta-analyses, Trial Sequential Analysis, and GRADE assessments were conducted. Results Three trials, randomising a total of 291 participants, evaluated PCC against two different active comparators in participants with VKA-related critical bleeding, and two trials, randomising a total of 534 participants, evaluated PCC against two different active comparators in participants with factor Xa-related critical bleeding. Among participants with VKA-related critical bleeding, meta-analyses showed no evidence of a difference between PCC versus fresh frozen plasma (FFP) when assessing all-cause mortality (risk ratio [RR] 1.05; 95% confidence interval (CI) 0.27 to 4.05; low certainty), health-related quality of life (mean difference 1.04; 95% CI − 0.94 to 3.02; very low certainty), and serious adverse events (RR 1.33; 95% CI 0.94 to 1.88; very low certainty), but information is currently sparse. Among participants with factor Xa-related critical bleeding, PCC could not be shown superior or inferior to other reversal strategies (FFP or andexanet alfa) on any patient-relevant outcome, but information is currently sparse. Conclusion Among participants with VKA or DOAC-related critical bleeding, evidence from randomised clinical trials is currently insufficient to establish if PCC is superior or inferior versus other interventions in decreasing the risk of undesirable patient-relevant outcomes or improving health-related quality of life.https://doi.org/10.1186/s13049-025-01334-1Prothrombin complex concentrateAnticoagulantsVitamin K antagonistDirect oral anticoagulantsBleedingSystematic review |
| spellingShingle | Christian Ovesen Jan Purrucker Josefine Grundtvig Theis Bech Mikkelsen Christian Gluud Janus Christian Jakobsen Hanne Christensen Thorsten Steiner Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trials Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine Prothrombin complex concentrate Anticoagulants Vitamin K antagonist Direct oral anticoagulants Bleeding Systematic review |
| title | Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trials |
| title_full | Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trials |
| title_fullStr | Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trials |
| title_full_unstemmed | Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trials |
| title_short | Prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation-related critical bleeding: a systematic review of randomised clinical trials |
| title_sort | prothrombin complex concentrate for reversal of oral anticoagulants in patients with oral anticoagulation related critical bleeding a systematic review of randomised clinical trials |
| topic | Prothrombin complex concentrate Anticoagulants Vitamin K antagonist Direct oral anticoagulants Bleeding Systematic review |
| url | https://doi.org/10.1186/s13049-025-01334-1 |
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