Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Total blood loss by the 3rd postoperative day
Study Overview
Brief Summary
The purpose of this study is to determine which of the following drugs: enoxaparin, dabigatran and rivaroxaban causes least blood loss after total hip replacement (THR).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •primary, end-stage hip osteoarthritis requiring total hip arthroplasty
Exclusion Criteria
- •inflammatory arthropathies
- •liver disorders
- •neoplastic conditions
- •clotting disorders
Arms & Interventions
enoxaparin
enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days
Intervention: Enoxaparin (Drug)
rivaroxaban
rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery
Intervention: rivaroxaban (Drug)
dabigatran
dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery
Intervention: dabigatran (Drug)
Outcomes
Primary Outcomes
Total blood loss by the 3rd postoperative day
Time Frame: 3rd day postoperatively
Measured for each individual. Measured according to the formula described by Nadler, Hidalgo and Bloch (Prediction of blood volume in normal human adults. Surgery 1962;51:224-32).
Secondary Outcomes
- Drop in the haemoglobin value between 3rd day postop and preoperative(3rd day postopertively)
- Wound healing disturbances according to the definition of Centers for Disease Control and Prevention(3 months postoperatively)
Investigators
Marcin Wasko MD PhD
Dr Marcin Wasko MD PhD
Centre of Postgraduate Medical Education