ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
NCT ID: NCT06611319
Last Updated: 2025-01-16
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
2932 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-11-26
Study Completion Date
2027-07-31
Brief Summary
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Surgical hip replacement (total hip arthroplasty, THA) is associated with a high risk of venous thromboembolism, but the appropriate duration of postoperative medical thromboprophylaxis ("anticoagulation") remains highly controversial. The international randomized controlled trial (RCT) "ENhanced recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis after primary Hip Arthroplasty" (ENABLE-Hip) will enroll patients undergoing elective THA that are eligible for early mobilization after surgery. The trial will compare a regimen of short-duration (10-day) postoperative anticoagulation (experimental group) to standard-duration (35-day) postoperative anticoagulation (control group) using the direct oral anticoagulant Rivaroxaban (brand name: Xarelto) at the recommended dose. Thus, ENABLE-Hip will be the first major RCT to directly test an overall reduction in the duration of post-THA thromboprophylaxis instead of replacing one antithrombotic drug or regimen by another. Follow-up visits after hospital discharge will be on day 35 and on day 90 after surgery. The primary outcome is acute symptomatic proximal deep vein thrombosis, or symptomatic or fatal pulmonary embolism, within 90 days after surgery. If ENABLE-Hip will demonstrate 'non-inferiority' of the experimental intervention, its benefits will be obvious, as patients are spared many days of unnecessary (and potentially harmful in terms of bleeding risk) anticoagulation.
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Detailed Description
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An increasing proportion of the ageing population in Europe and other parts of the world suffers from hip osteoarthritis and will need surgical joint arthroplasty at some time in their lives. Surgical total hip arthroplasty (THA) is associated with a high risk of venous thromboembolism (VTE), but the appropriate duration of postoperative anticoagulation remains highly controversial. Although current German guidelines continue to advocate anticoagulation for 28-35 days after THA, clinical practice recommendations in other countries are shifting towards much earlier discontinuation of anticoagulants - despite the absence of solid evidence backed by controlled data. The "Enhanced recovery and Abbreviated duration of Anticoagulation for thromboprophylaxis after primary hip Arthroplasty" (ENABLE-Hip) study is a multicentre investigator-initiated and academically sponsored prospective randomised active-control non-inferiority trial. A regimen of short-duration (10-day) prophylactic anticoagulation (experimental arm) will be compared to standard-duration (35-day) anticoagulation as per current guidelines (control arm). Patients will be mobilised early after surgery, following a standardised enhanced recovery protocol. Following randomisation and an initial two-day open-label period of prophylactic anticoagulation as per local protocol, treatment with the study drug (rivaroxaban at the standard, approved prophylactic dose of 10 mg daily) will be started and continued until 10 days after surgery. After this time, patients will be switched (in a double-blinded manner) to placebo in the experimental arm, or continue on active drug in the control arm, until a total of 35 days have elapsed since surgery. The primary outcome is acute symptomatic proximal deep vein thrombosis (DVT), or symptomatic or fatal pulmonary embolism (PE), within the first 3 months after surgery. Participating investigators will be advised to adhere to guideline recommendations regarding clinical suspicion of and diagnostic work-up for VTE. The planned study population of 2,932 patients will provide ≥ 80% power to reject the null hypothesis that δ ≥ 0.01 (where δ = difference between the two arms in symptomatic VTE probability within 3 months) and accept the alternative hypothesis that δ \< 0.01, at an overall significance level α = 0.05. A formal interim analysis will be performed after 3-month follow-up of the first 1,760 randomised patients at a significance level α = 0.50, leading to stopping for futility if significance is not obtained, or if recalculation yields an overall sample size of \> 3,200 patients. The trial has the potential to inform future national and European guidelines for this large and continuously growing patient population.
Conditions
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Hip Arthroplasty, Total
Prevention of Venous Thromboembolism
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Investigator-initiated and academically sponsored multicenter randomized double blind active-control non-inferiority trial
Primary Study Purpose
PREVENTION
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Abbreviated lenght of thromboprophylaxis
Rivaroxaban from day 3-10; Placebo from day 11-35 after surgery
Group Type
EXPERIMENTAL
Prevention of Venous Thromboembolism
Intervention Type
DRUG
Direct oral anticoagulant
Placebo Oral Tablet
Intervention Type
DRUG
Placebo
Standard of care
Rivaroxaban from day 3-35 after surgery
Group Type
ACTIVE_COMPARATOR
Prevention of Venous Thromboembolism
Intervention Type
DRUG
Direct oral anticoagulant
Interventions
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Prevention of Venous Thromboembolism
Direct oral anticoagulant
Intervention Type
DRUG
Placebo Oral Tablet
Placebo
Intervention Type
DRUG
Other Intervention Names
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Rivaroxaban
Xarelto
anticoag
Direct oral anticoagulant
DOAC
Eligibility Criteria
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Inclusion Criteria
1. Written informed consent
2. Age between 18 and 85 years
3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol
4. Baseline Timed Up and Go (TUG) test scoring \&lt; 20 seconds, corresponding to a good mobility status before surgery
5. Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules).
6. Pregnancy and contraception:
1. Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).
2. Contraception: WOCBP and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and allowing for a safe wash out period of at least 5 days for female or for male subjects after the last dose of trial medication. This is a very conservative estimate, considering the 'worst case scenario' of a substantially prolonged half-life up to 13 hours (e.g., in older patients and/or those with renal dysfunction) (28), and calculating for at least 8 half-lives to ensure practically non-detectable levels and effects of rivaroxaban.
2. Age between 18 and 85 years
3. Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol
4. Baseline Timed Up and Go (TUG) test scoring \&lt; 20 seconds, corresponding to a good mobility status before surgery
5. Capability to understand and comply with the protocol requirements (e.g., sufficient knowledge of German language to answer the questionnaires, ability to swallow intact capsules).
6. Pregnancy and contraception:
1. Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).
2. Contraception: WOCBP and men who are able to father a child, willing to be abstinent or use highly effective methods of birth control that result in a low failure rate of less than 1% per year when used consistently and correctly beginning at informed consent, for the duration of drug treatment and allowing for a safe wash out period of at least 5 days for female or for male subjects after the last dose of trial medication. This is a very conservative estimate, considering the 'worst case scenario' of a substantially prolonged half-life up to 13 hours (e.g., in older patients and/or those with renal dysfunction) (28), and calculating for at least 8 half-lives to ensure practically non-detectable levels and effects of rivaroxaban.
Exclusion Criteria
1. Previous DVT or PE
2. Hip or lower limb fracture in the previous three months
3. Major surgical procedure within the previous three months
4. Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy
5. Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
6. Obesity with body mass index (BMI) \&gt; 40 kg/m2 body surface area
7. Severe renal impairment defined as estimated glomerular filtration rate \&lt; 30ml/min
8. Severe hepatic impairment defined as Child Pugh Class B or C
9. Uncontrolled intercurrent illness (i.e., active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious gastrointestinal conditions \[e.g., diarrhea, malabsorption\], psychiatric illness)
10. Active or recent major bleeding at any site, or presence of any major risk factor for bleeding, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment
11. Any other medical condition representing a contraindication to discharge within 6 days after surgery
12. Expected requirement for major surgery within a 90-day period post THA
13. Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
14. Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily
15. Previous participation in this trial
16. Life expectancy \&lt; 6 months
17. Participation in another interventional clinical trial within the last 30 days prior to inclusion, unless during the observational follow-up period
18. History of hypersensitivity to the investigational medicinal product (IMP) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP
2. Hip or lower limb fracture in the previous three months
3. Major surgical procedure within the previous three months
4. Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy
5. Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
6. Obesity with body mass index (BMI) \&gt; 40 kg/m2 body surface area
7. Severe renal impairment defined as estimated glomerular filtration rate \&lt; 30ml/min
8. Severe hepatic impairment defined as Child Pugh Class B or C
9. Uncontrolled intercurrent illness (i.e., active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, interstitial lung disease, serious gastrointestinal conditions \[e.g., diarrhea, malabsorption\], psychiatric illness)
10. Active or recent major bleeding at any site, or presence of any major risk factor for bleeding, which, in the judgment of the investigator, may significantly increase the bleeding risk during postoperative anticoagulation treatment
11. Any other medical condition representing a contraindication to discharge within 6 days after surgery
12. Expected requirement for major surgery within a 90-day period post THA
13. Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
14. Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily
15. Previous participation in this trial
16. Life expectancy \&lt; 6 months
17. Participation in another interventional clinical trial within the last 30 days prior to inclusion, unless during the observational follow-up period
18. History of hypersensitivity to the investigational medicinal product (IMP) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the IMP
Minimum Eligible Age
18 Years
Maximum Eligible Age
85 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Prof. Stavros Konstantinides, MD
OTHER
Sponsor Role
lead
Responsible Party
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Prof. Stavros Konstantinides, MD
Univ.-Prof.
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Stavros V. Konstantinides, MD, Univ.-Prof.
Role: STUDY_CHAIR
University Medical Center Mainz, Center for Thrombosis and Hemostasis
Philipp Drees, MD, Univ.-Prof.
Role: STUDY_CHAIR
University Medical Center Mainz, Center for Orthopedics and Trauma Surgery
Locations
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Kepler University Medical Center, Orthopedics and Traumatology
Linz, Upper Austria, Austria
Site Status
RECRUITING
Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics
Kremmen, Brandenburg, Germany
Site Status
RECRUITING
GPR Rüsselsheim Health and Care Center
Rüsselsheim am Main, Hesse, Germany
Site Status
RECRUITING
University Medical Center Mainz, Center for Orthopedics and Trauma Surgery
Mainz, Rhineland-Palatine, Germany
Site Status
RECRUITING
University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery
Dresden, Saxony, Germany
Site Status
RECRUITING
Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery
Berlin, , Germany
Site Status
RECRUITING
Countries
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Austria
Germany
Central Contacts
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Facility Contacts
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References
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Schulman S, Angeras U, Bergqvist D, Eriksson B, Lassen MR, Fisher W; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients. J Thromb Haemost. 2010 Jan;8(1):202-4. doi: 10.1111/j.1538-7836.2009.03678.x. Epub 2009 Oct 30.
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BACKGROUND
Mazzolai L, Ageno W, Alatri A, Bauersachs R, Becattini C, Brodmann M, Emmerich J, Konstantinides S, Meyer G, Middeldorp S, Monreal M, Righini M, Aboyans V. Second consensus document on diagnosis and management of acute deep vein thrombosis: updated document elaborated by the ESC Working Group on aorta and peripheral vascular diseases and the ESC Working Group on pulmonary circulation and right ventricular function. Eur J Prev Cardiol. 2022 May 27;29(8):1248-1263. doi: 10.1093/eurjpc/zwab088.
Reference Type
BACKGROUND
Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
Reference Type
BACKGROUND
Ghosh A, Best AJ, Rudge SJ, Chatterji U. Clinical Effectiveness of Aspirin as Multimodal Thromboprophylaxis in Primary Total Hip and Knee Arthroplasty: A Review of 6078 Cases. J Arthroplasty. 2019 Jul;34(7):1359-1363. doi: 10.1016/j.arth.2019.03.021. Epub 2019 Mar 13.
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BACKGROUND
Brown GA. Venous thromboembolism prophylaxis after major orthopaedic surgery: a pooled analysis of randomized controlled trials. J Arthroplasty. 2009 Sep;24(6 Suppl):77-83. doi: 10.1016/j.arth.2009.06.002. Epub 2009 Jul 22.
Reference Type
BACKGROUND
Drees P, Schmidtmann I, Herbst M, Becker D, Barco S, Klok FA, Keller K, Hobohm L, Christodoulou KC, Abele C, Bauersachs R, Ageno W, Grove EL, Kehlet H, Hufen F, Klonschinski T, Afghanyar Y, Eckhard L, Martin N, Fischer S, Gorbulev S, Rath D, Mavromanoli AC, Jabbour C, Lang I, Couturaud F, Heiss C, Binder H, Konstantinides S. Enhanced recovery and abbreviated length of anticoagulation for thromboprophylaxis after primary hip arthroplasty rationale and design of the ENABLE-hip trial. J Thromb Thrombolysis. 2025 Aug;58(6):689-698. doi: 10.1007/s11239-025-03110-5. Epub 2025 May 29.
Reference Type
DERIVED
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-507490-18-00
Identifier Type: CTIS
Identifier Source: secondary_id
23-01496
Identifier Type: -
Identifier Source: org_study_id
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