Delphine Douillet, Karim Tazarourte, Emilie Dehours, Christian Brice, Hery Andrianjafy, Albert Trinh-Duc, Sigismond Lasocki, Matthieu Labriffe, Jérémie Riou, Pierre-Marie Roy
{"title":"用凝血酶原复合物浓缩物逆转轻度脑外伤患者体内的维生素 K 拮抗剂：随机对照试验。","authors":"Delphine Douillet, Karim Tazarourte, Emilie Dehours, Christian Brice, Hery Andrianjafy, Albert Trinh-Duc, Sigismond Lasocki, Matthieu Labriffe, Jérémie Riou, Pierre-Marie Roy","doi":"10.1097/MEJ.0000000000001199","DOIUrl":null,"url":null,"abstract":"<p><strong>Background and importance: </strong>Traumatic brain injury (TBI) in patients on vitamin K antagonists (VKAs) is linked to a high rate of intracranial hemorrhage (ICH). Rapid reversal can reduce ICH progression and mortality, but its effectiveness depends on the time between bleeding onset and coagulation normalization.</p><p><strong>Objective: </strong>The PREVACT study aimed to assess the efficacy and safety of prompt systematic reversal of anticoagulation in patients presenting to emergency departments (EDs) for recent mild-TBI while receiving a VKA.</p><p><strong>Intervention: </strong>A randomized, open-label, blinded-endpoint clinical trial was conducted in 21 French EDs. Patients receiving a VKA, having experienced a TBI within the last 6 h, and presenting a Glasgow Coma Score ≥13 were included. Patients were randomized to systematic immediate VKA reversal with 25 IU/kg of four-factor prothrombin complex concentrate (4f-PCC) before any investigation (intervention group) or standard-of-care signifying reversal only if the initial cranial computed tomography (CT) scan indicated ICH (control group). The primary outcome was the rate of ICH detected on a cranial CT scan 24 h post-inclusion.</p><p><strong>Results: </strong>The study was prematurely stopped for logistic reasons after the randomization of 202 patients (101 and 101 in the intervention and control groups, respectively, mean age 90; 51.8% female). On the 24-h cranial CT scan, 6 of 98 patients (6.1%) in the intervention group manifested ICH vs. 12 of 99 patients (12.1%) in the control group [odds ratio: 0.47 (95% confidence interval: 0.14-1.44); P = 0.215].</p><p><strong>Conclusion: </strong>In patients with recent mild-TBI receiving a VKA, systematic prompt reversal with 4f-PCC did not statistically significantly reduce ICH rate at 24 h. However, the study was prematurely stopped and does not exclude a clinically relevant benefit of the strategy tested.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov (NCT01961804).</p>","PeriodicalId":11893,"journal":{"name":"European Journal of Emergency Medicine","volume":null,"pages":null},"PeriodicalIF":3.1000,"publicationDate":"2024-11-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial.\",\"authors\":\"Delphine Douillet, Karim Tazarourte, Emilie Dehours, Christian Brice, Hery Andrianjafy, Albert Trinh-Duc, Sigismond Lasocki, Matthieu Labriffe, Jérémie Riou, Pierre-Marie Roy\",\"doi\":\"10.1097/MEJ.0000000000001199\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background and importance: </strong>Traumatic brain injury (TBI) in patients on vitamin K antagonists (VKAs) is linked to a high rate of intracranial hemorrhage (ICH). Rapid reversal can reduce ICH progression and mortality, but its effectiveness depends on the time between bleeding onset and coagulation normalization.</p><p><strong>Objective: </strong>The PREVACT study aimed to assess the efficacy and safety of prompt systematic reversal of anticoagulation in patients presenting to emergency departments (EDs) for recent mild-TBI while receiving a VKA.</p><p><strong>Intervention: </strong>A randomized, open-label, blinded-endpoint clinical trial was conducted in 21 French EDs. Patients receiving a VKA, having experienced a TBI within the last 6 h, and presenting a Glasgow Coma Score ≥13 were included. Patients were randomized to systematic immediate VKA reversal with 25 IU/kg of four-factor prothrombin complex concentrate (4f-PCC) before any investigation (intervention group) or standard-of-care signifying reversal only if the initial cranial computed tomography (CT) scan indicated ICH (control group). The primary outcome was the rate of ICH detected on a cranial CT scan 24 h post-inclusion.</p><p><strong>Results: </strong>The study was prematurely stopped for logistic reasons after the randomization of 202 patients (101 and 101 in the intervention and control groups, respectively, mean age 90; 51.8% female). On the 24-h cranial CT scan, 6 of 98 patients (6.1%) in the intervention group manifested ICH vs. 12 of 99 patients (12.1%) in the control group [odds ratio: 0.47 (95% confidence interval: 0.14-1.44); P = 0.215].</p><p><strong>Conclusion: </strong>In patients with recent mild-TBI receiving a VKA, systematic prompt reversal with 4f-PCC did not statistically significantly reduce ICH rate at 24 h. However, the study was prematurely stopped and does not exclude a clinically relevant benefit of the strategy tested.</p><p><strong>Trial registration: </strong>Clinicaltrials.gov (NCT01961804).</p>\",\"PeriodicalId\":11893,\"journal\":{\"name\":\"European Journal of Emergency Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.1000,\"publicationDate\":\"2024-11-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"European Journal of Emergency Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1097/MEJ.0000000000001199\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"EMERGENCY MEDICINE\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"European Journal of Emergency Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1097/MEJ.0000000000001199","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"EMERGENCY MEDICINE","Score":null,"Total":0}
Systematic vitamin K antagonist reversal with prothrombin complex concentrate in patients with mild traumatic brain injury: randomized controlled trial.
Background and importance: Traumatic brain injury (TBI) in patients on vitamin K antagonists (VKAs) is linked to a high rate of intracranial hemorrhage (ICH). Rapid reversal can reduce ICH progression and mortality, but its effectiveness depends on the time between bleeding onset and coagulation normalization.
Objective: The PREVACT study aimed to assess the efficacy and safety of prompt systematic reversal of anticoagulation in patients presenting to emergency departments (EDs) for recent mild-TBI while receiving a VKA.
Intervention: A randomized, open-label, blinded-endpoint clinical trial was conducted in 21 French EDs. Patients receiving a VKA, having experienced a TBI within the last 6 h, and presenting a Glasgow Coma Score ≥13 were included. Patients were randomized to systematic immediate VKA reversal with 25 IU/kg of four-factor prothrombin complex concentrate (4f-PCC) before any investigation (intervention group) or standard-of-care signifying reversal only if the initial cranial computed tomography (CT) scan indicated ICH (control group). The primary outcome was the rate of ICH detected on a cranial CT scan 24 h post-inclusion.
Results: The study was prematurely stopped for logistic reasons after the randomization of 202 patients (101 and 101 in the intervention and control groups, respectively, mean age 90; 51.8% female). On the 24-h cranial CT scan, 6 of 98 patients (6.1%) in the intervention group manifested ICH vs. 12 of 99 patients (12.1%) in the control group [odds ratio: 0.47 (95% confidence interval: 0.14-1.44); P = 0.215].
Conclusion: In patients with recent mild-TBI receiving a VKA, systematic prompt reversal with 4f-PCC did not statistically significantly reduce ICH rate at 24 h. However, the study was prematurely stopped and does not exclude a clinically relevant benefit of the strategy tested.
期刊介绍：
The European Journal of Emergency Medicine is the official journal of the European Society for Emergency Medicine. It is devoted to serving the European emergency medicine community and to promoting European standards of training, diagnosis and care in this rapidly growing field.
Published bimonthly, the Journal offers original papers on all aspects of acute injury and sudden illness, including: emergency medicine, anaesthesiology, cardiology, disaster medicine, intensive care, internal medicine, orthopaedics, paediatrics, toxicology and trauma care. It addresses issues on the organization of emergency services in hospitals and in the community and examines postgraduate training from European and global perspectives. The Journal also publishes papers focusing on the different models of emergency healthcare delivery in Europe and beyond. With a multidisciplinary approach, the European Journal of Emergency Medicine publishes scientific research, topical reviews, news of meetings and events of interest to the emergency medicine community.
Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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