Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06611319
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ENhanced Recovery and ABbreviated LEngth of Anticoagulation for Thromboprophylaxis After Primary Hip Arthroplasty
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ENABLE-Hip
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
Detailed Description:
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 2932 patients will provide 80 power to reject the null hypothesis that δ 001 where δ difference between the two arms in symptomatic VTE probability within 3 months and accept the alternative hypothesis that δ 001 at an overall significance level α 005 A formal interim analysis will be performed after 3-month follow-up of the first 1760 randomised patients at a significance level α 050 leading to stopping for futility if significance is not obtained or if recalculation yields an overall sample size of 3200 patients The trial has the potential to inform future national and European guidelines for this large and continuously growing patient population
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None