ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-85
SponsorProf. Stavros Konstantinides, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Prevention of Venous Thromboembolism
DrugDirect oral anticoagulant
Placebo Oral Tablet
DrugPlacebo
Treatment groups
2,932 Participants
are divided into 2 treatment groupsGroup A: Abbreviated lenght of thromboprophylaxisExperimental treatment 2 interventions
Group B: Standard of careActive comparator 1 intervention
Trial outcomes
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.
Time frame
within 90 days after surgerySecondary outcomes
1
Length of hospital stay
duration of inpatient stay
Time frame
within 90 days after surgery2
Changes in patient-reported hip joint-specific disability
assessment is made following surgery measured by the HOOS-12 score
Time frame
within 90 days after surgery3
Rate of clinically relevant non-major bleedings
it does not meet the criteria for major bleeding, but results in hospitalization, aspiration of a wound, or a wound hematoma complicated by infection.
Time frame
within 90 days after surgery4
Rate of death from any cause
rate of death from any cause
Time frame
within 90 days after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Prof. Stavros Konstantinides, MD
Lead sponsor
Johannes Gutenberg University Mainz
Sponsor institution
Source ClinicalTrials.gov