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

March 13, 2014 updated by: Marcin Wasko MD PhD, Centre of Postgraduate Medical Education
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Woj. Mazowieckie
      • Otwock, Woj. Mazowieckie, Poland, 05-400
        • Recruiting
        • Prof. A. Gruca Teaching Hospital, The Medical Centre of Postgraduate Education
        • Principal Investigator:
          • Marcin K Wasko, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3rd day postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drop in the haemoglobin value between 3rd day postop and preoperative
Time Frame: 3rd day postopertively
Difference between haemoglobin on the 3rd postopertive day and day before operation
3rd day postopertively
Wound healing disturbances according to the definition of Centers for Disease Control and Prevention
Time Frame: 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)
3 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre of Postgraduate Medical Education

Investigators

  • Principal Investigator: Marcin K Wasko, M.D., Ph.D., The Medical Centre of Postgraduate Education, Department of Orthopaedics and Inflammatory Disorders of Locomotor System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

April 1, 2014

Study Completion (Anticipated)

April 1, 2014

Study Registration Dates

First Submitted

March 7, 2014

First Submitted That Met QC Criteria

March 7, 2014

First Posted (Estimate)

March 13, 2014

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 13, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPX-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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