ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty

NCT06611319 | Recruiting Phase 3 DMC

• 2 other identifiers: 23-014962023-507490-18-00
• Study Type: interventional
• Target: 2,932
• Locations: 2 countries
• Sites: 6

Brief Summary

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.

Conditions

Hip Arthroplasty, Total; Prevention of Venous Thromboembolism

Keywords

Thromboprophylaxis after hip surgery; Rivaroxaban; Abbreviated length of Anticoagulation; Enhanced recovery after surgery; Fast-track surgery; Early mobilization; Pulmonary embolism; Deep vein thrombosis

Outcome Measures

Primary Outcomes (1)

• The primary efficacy endpoint is the rate of acute symptomatic or fatal VTE

  acute symptomatic or fatal VTE, defined as (i) symptomatic DVT of the popliteal or more proximal leg veins (femoral or iliac veins) or inferior vena cava; or (ii) symptomatic (segmental or more proximal) or fatal PE, occurring in the first 90 days after surgery and confirmed by objective testing.

  within 90 days after surgery

Secondary Outcomes (12)

• Length of hospital stay

  within 90 days after surgery

• Changes in patient-reported hip joint-specific disability

  within 90 days after surgery

• Rate of clinically relevant non-major bleedings

  within 90 days after surgery

• Rate of death from any cause

  within 90 days after surgery

• Rate of isolated symptomatic distal DVT

  within 90 days after surgery

Study Arms (2)

Abbreviated lenght of thromboprophylaxis

EXPERIMENTAL

Rivaroxaban from day 3-10; Placebo from day 11-35 after surgery

Drug: Prevention of Venous Thromboembolism; Drug: Placebo Oral Tablet

Standard of care

ACTIVE COMPARATOR

Rivaroxaban from day 3-35 after surgery

Drug: Prevention of Venous Thromboembolism

Interventions

Prevention of Venous Thromboembolism DRUG

Direct oral anticoagulant

Also known as: Rivaroxaban, Xarelto, anticoag, Direct oral anticoagulant, DOAC

Abbreviated lenght of thromboprophylaxis; Standard of care

Placebo Oral Tablet DRUG

Placebo

Abbreviated lenght of thromboprophylaxis

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Age between 18 and 85 years
• Scheduled to undergo elective unilateral primary THA and eligible for perioperative management based on the ERAS protocol
• Baseline Timed Up and Go (TUG) test scoring \< 20 seconds, corresponding to a good mobility status before surgery
• 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).
• Pregnancy and contraception:
• Pregnancy test: Negative serum pregnancy test at screening for women of childbearing potential (WOCBP).
• 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.

You may not qualify if:

• Previous DVT or PE
• Hip or lower limb fracture in the previous three months
• Major surgical procedure within the previous three months
• Active cancer defined as metastatic cancer, or cancer requiring chemotherapy or radiation therapy
• Active peptic ulcer disease, gastritis, or prior gastrointestinal bleeding
• Obesity with body mass index (BMI) \> 40 kg/m2 body surface area
• Severe renal impairment defined as estimated glomerular filtration rate \< 30ml/min
• Severe hepatic impairment defined as Child Pugh Class B or C
• 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)
• 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
• Any other medical condition representing a contraindication to discharge within 6 days after surgery
• Expected requirement for major surgery within a 90-day period post THA
• Need for long-term anticoagulation (e.g., atrial fibrillation, previous VTE)
• Need for chronic antiplatelet therapy except for acetylsalicylic acid (ASA) at a dose ≤ 100 mg daily or clopidogrel 75 mg daily
• Previous participation in this trial

Sponsors & Collaborators

• Prof. Stavros Konstantinides, MD: lead

Study Sites (6)

Kepler University Medical Center, Orthopedics and Traumatology

Linz, Upper Austria, 4020, Austria

RECRUITING

Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics

Kremmen, Brandenburg, 16766, Germany

RECRUITING

GPR Rüsselsheim Health and Care Center

Rüsselsheim am Main, Hesse, 65428, Germany

RECRUITING

University Medical Center Mainz, Center for Orthopedics and Trauma Surgery

Mainz, Rhineland-Palatine, 55131, Germany

RECRUITING

University Medical Center Dresden, University Center for Orthopaedics, Trauma & Plastic Surgery

Dresden, Saxony, 01307, Germany

RECRUITING

Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery

Berlin, 13589, Germany

RECRUITING

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MeSH Terms

Conditions

Pulmonary Embolism; Venous Thrombosis

Interventions

Rivaroxaban; N(4)-oleylcytosine arabinoside

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Thrombosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Stavros V. Konstantinides, MD, Univ.-Prof.

  University Medical Center Mainz, Center for Thrombosis and Hemostasis

  STUDY CHAIR

• Philipp Drees, MD, Univ.-Prof.

  University Medical Center Mainz, Center for Orthopedics and Trauma Surgery

  STUDY CHAIR

Central Study Contacts

Nadine Martin, Dr.

CONTACT

+496131178376; nadine.martin@unimedizin-mainz.de

Susanne Fischer, M.Sc.

CONTACT

+496131178382; susanne.fischer@unimedizin-mainz.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Univ.-Prof.

Model Details: Investigator-initiated and academically sponsored multicenter randomized double blind active-control non-inferiority trial

Study Record Dates

• First Submitted: September 23, 2024
• First Posted: September 24, 2024
• Study Start: November 26, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1); DE (5)