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

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.

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Journal
Journal of Thrombosis and Thrombolysis
Published
2025-05-29
DOI
https://doi.org/10.1007/s11239-025-03110-5
Citations
2
Primary Topic
Venous Thromboembolism Diagnosis and Management
Type
article
Field-Weighted Citation Impact
3.74

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article

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

Irene Schmidtmann, Harald Binder, Erik Lerkevang Grove, Lukas Eckhard et al.
2 citations
Journal of Thrombosis and Thrombolysis
Venous Thromboembolism Diagnosis and Management
3.74
article

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

Irene Schmidtmann, Harald Binder, Erik Lerkevang Grove, Lukas Eckhard, Stanislav Gorbulev, Christina Abele, Henrik Kehlet, Stefano Barco, Susanne Fischer, Manuel Herbst, Stavros Konstantinides, Konstantinos Christodoulou, Dominik Rath, Thomas Klonschinski, Karsten Keller, Philipp Drees, Frederikus Albertus Klok, Anna C. Mavromanoli, Françis Couturaud, Iréne Lang, Dorothea Becker, Walter Ageno, Yama Afghanyar, Lukas Hobohm, Rupert Bauersachs, Christian Heiß, Nadine Martin, Claude Jabbour, Friedhelm Hufen
article en
2 citations

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.

Journal of Thrombosis and ThrombolysisVol. 58(6)
Saint-Gobain (France) (FR), University of Padua (IT), Inserm (FR), University of Freiburg (DE), Johannes Gutenberg University Mainz (DE), Justus-Liebig-Universität Gießen (DE), Aarhus University (DK), Heidelberg University (DE), Leiden University Medical Center (NL), University Hospital Heidelberg (DE), Aarhus University Hospital (DK), Rigshospitalet (DK), Cardiovascular Center Bethanien (DE), University Medical Center of the Johannes Gutenberg University Mainz (DE), University Hospital of Zurich (CH), University Children's Hospital Tübingen (DE), Centre Hospitalier Régional Universitaire de Brest (FR), Joint Research Centre (DE), University Medical Centre Mannheim (DE), Medical University of Vienna (AT)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Good health and well-being
Openalex Percentile: Top 7%
Venous Thromboembolism Diagnosis and Management
3.74
DOIOpen Access PDFOpenAlex
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