Comparison of Blood Loss Following Total Hip Arthroplasty With the Use of Three Thromboprophylactic Regimes: Dabigatran, Enoxaparin and Rivaroxaban.

Not Applicable

• Conditions: Hip Osteoarthritis; Blood Loss
• Interventions: Drug: Enoxaparin; Drug: dabigatran; Drug: rivaroxaban

• Registration Number: NCT02085824
• Lead Sponsor: Centre of Postgraduate Medical Education

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Status Verified: 2014-03
• Study First Submitted: 2014-03-07
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-13
• Last Update Submitted: 2014-03-13
• Last Update Posted: 2014-03-14
• Primary Completion: 2014-04
• Study Completion: 2014-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• primary, end-stage hip osteoarthritis requiring total hip arthroplasty

Exclusion Criteria

• inflammatory arthropathies
• liver disorders
• neoplastic conditions
• clotting disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
enoxaparin	Enoxaparin	enoxaparin 40mg 1x1 s.c. daily, once preoperatively and then daily for 28 days
dabigatran	dabigatran	dabigatran 110 mg 1x1 p.o. postoperatively and then 1x2 p.o. for 27 days after the surgery
rivaroxaban	rivaroxaban	rivaroxaban 10 mg 1x1 p.o. daily for 28 days after the surgery

Primary Outcome Measures

Name	Time	Method
Total blood loss by the 3rd postoperative day	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 Outcome Measures

Name	Time	Method
Drop in the haemoglobin value between 3rd day postop and preoperative	3rd day postopertively	Difference between haemoglobin on the 3rd postopertive day and day before operation
Wound healing disturbances according to the definition of Centers for Disease Control and Prevention	3 months postoperatively	Wound healing disturbances - diagnosis to be made according to the definition of Centers for Disease Control and Prevention (Mangram, Horan, Pearson, Silver and Jarvis. Guideline for prevention of surgical site infection, 1999. Hospital Infection Control Practices Advisory Committee. Infect Control Hosp Epidemiol. 1999 Apr;20(4):250-78)

Trial Locations

Locations (1)

Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education; 🇵🇱 Otwock, Woj. Mazowieckie, Poland