Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT06611319
PHASE3

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

Sponsor: Prof. Stavros Konstantinides, MD

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

2932

Start Date

2024-11-26

Completion Date

2027-07

Last Updated

2025-01-16

Healthy Volunteers

No

Interventions

DRUG

Prevention of Venous Thromboembolism

Direct oral anticoagulant

DRUG

Placebo Oral Tablet

Placebo

Locations (6)

Kepler University Medical Center, Orthopedics and Traumatology

Linz, Upper Austria, Austria

Sana Clinics Sommerfeld, Dpt. for Surgical Orthopaedics

Kremmen, Brandenburg, Germany

GPR Rüsselsheim Health and Care Center

Rüsselsheim am Main, Hesse, Germany

University Medical Center Mainz, Center for Orthopedics and Trauma Surgery

Mainz, Rhineland-Palatine, Germany

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

Dresden, Saxony, Germany

Evangelical Forest Hospital Berlin - Orthopaedics and Trauma Surgery

Berlin, Germany