Enhanced recovery and abbreviated length of anticoagulation for thromboprophylaxis after primary hip arthroplasty rationale and design of the ENABLE-hip trial.

IF 2.3 3区 医学 Q2 CARDIAC & CARDIOVASCULAR SYSTEMS
Philipp Drees, Irene Schmidtmann, Manuel Herbst, Dorothea Becker, Stefano Barco, Frederikus A Klok, Karsten Keller, Lukas Hobohm, Konstantinos C Christodoulou, Christina Abele, Rupert Bauersachs, Walter Ageno, Erik Lerkevang Grove, Henrik Kehlet, Friedhelm Hufen, Thomas Klonschinski, Yama Afghanyar, Lukas Eckhard, Nadine Martin, Susanne Fischer, Stanislav Gorbulev, Dominik Rath, Anna C Mavromanoli, Claude Jabbour, Irene Lang, Francis Couturaud, Christian Heiss, Harald Binder, Stavros Konstantinides
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引用次数: 0

Abstract

Surgical total hip arthroplasty (THA) is associated with high risk of venous thromboembolism (VTE), but the appropriate duration of postoperative anticoagulation remains controversial. "Enhanced Recovery and Abbreviated Length of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty" (ENABLE-Hip) is a multicenter investigator-initiated and academically sponsored randomized double-blind active-control non-inferiority trial. Patients will be mobilized early after surgery, following a standardized enhanced recovery protocol. After an initial open-label prophylactic anticoagulation as per local standard of care until day 2 after surgery, treatment with rivaroxaban (10 mg once daily) will be started on day 3 and continued until day 10. Subsequently, patients will be switched to placebo in the experimental arm, or continue on active drug in the control arm, until a total of 35 days. The primary endpoint is acute symptomatic or fatal VTE within 3 months. A sample size of 2,932 patients will provide ≥ 80% power to reject the null hypothesis that δ ≥ 0.01 (δ = difference between the two arms in symptomatic VTE probability) at a significance level α = 0.05. An interim analysis will be performed after 3-month follow-up of the first 1,760 randomized patients at a significance level α = 0.50, leading to stop for futility if significance is not obtained, or if recalculation yields a sample size of > 3,200 patients. ENABLE-Hip will be the first major randomized trial to test an overall reduction in the duration of post-THA thromboprophylaxis and will inform future guideline recommendations concerning this continuously growing patient population.Trial registration: ClinicalTrials.gov Identifier: NCT06611319.

初次髋关节置换术后抗凝治疗的恢复增强和缩短抗凝时间
手术全髋关节置换术(THA)与静脉血栓栓塞(VTE)的高风险相关,但术后适当的抗凝时间仍然存在争议。“原发性髋关节置换术后抗凝治疗的增强恢复和缩短抗凝时间”(ENABLE-Hip)是一项多中心研究者发起和学术赞助的随机双盲主动对照非效性试验。患者将在手术后早期动员起来,遵循标准化的增强恢复方案。术后第2天按照当地护理标准进行开放标签预防性抗凝治疗后,第3天开始使用利伐沙班(10mg,每日一次)治疗,并持续至第10天。随后,患者将在实验组中切换到安慰剂,或在对照组中继续使用活性药物,直到总共35天。主要终点是3个月内急性症状性或致死性静脉血栓栓塞。2,932例患者的样本量将提供≥80%的能力在显著性水平α = 0.05上拒绝δ≥0.01 (δ =两组间症状性静脉血栓栓塞概率的差异)的原假设。对首批1760名随机患者进行为期3个月的随访后进行中期分析,显著性水平α = 0.50,如果未获得显著性,或重新计算样本量为bbb3,200例患者,则终止无效。ENABLE-Hip将是首个主要的随机试验,以测试tha后血栓预防持续时间的总体减少,并将为未来关于这一不断增长的患者群体的指南建议提供信息。试验注册:ClinicalTrials.gov标识符:NCT06611319。
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来源期刊
CiteScore
9.20
自引率
0.00%
发文量
112
审稿时长
4-8 weeks
期刊介绍: The Journal of Thrombosis and Thrombolysis is a long-awaited resource for contemporary cardiologists, hematologists, vascular medicine specialists and clinician-scientists actively involved in treatment decisions and clinical investigation of thrombotic disorders involving the cardiovascular and cerebrovascular systems. The principal focus of the Journal centers on the pathobiology of thrombosis and vascular disorders and the use of anticoagulants, platelet antagonists, cell-based therapies and interventions in scientific investigation, clinical-translational research and patient care. The Journal will publish original work which emphasizes the interface between fundamental scientific principles and clinical investigation, stimulating an interdisciplinary and scholarly dialogue in thrombosis and vascular science. Published works will also define platforms for translational research, drug development, clinical trials and patient-directed applications. The Journal of Thrombosis and Thrombolysis'' integrated format will expand the reader''s knowledge base and provide important insights for both the investigation and direct clinical application of the most rapidly growing fields in medicine-thrombosis and vascular science.
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