Tranexamic Acid vs. Quixil - Reducing Blood Loss in Joint Replacement

May 13, 2008 updated by: Golden Jubilee National Hospital

Prospective Randomised Trial Comparing Intraoperative Topical Quixil and Intravenous Tranexamic Acid, in Reduction of Blood Loss Following Primary Hip & Knee Joint Replacement Surgery.

We will compare the effectiveness of Quixil and Tranexamic acid in reducing bleeding during hip and knee joint replacements.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective randomised controlled trial to compare the benefits of Quixil vs. Tranexamic acid in reducing blood loss.

Both medicines are used for the reduction of blood loss in major joint surgery; previous studies have shown each one to be effective and safe, but they have not been directly compared in this setting.

We will compare the blood loss in each of 3 groups: tranexamic acid used, Quixil used, and control group (neither drug used). Blood loss is to be calculated from height, body weight and difference between pre and post-operation haematocrit.

Study Type

Interventional

Enrollment (Actual)

132

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

  • United Kingdom
    • Scotland
      • Clydebank, Scotland, United Kingdom, G81 4HX
        • Golden Jubilee National Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who are to undergo elective hip or knee joint replacement
  • Must be cemented arthroplasty
  • Must be primary arthroplasty

Exclusion Criteria:

  • Uncemented arthroplasty.
  • Revision arthroplasty.
  • Patients on anticoagulant (warfarin, low molecular weight heparin) or other medication known to affect clotting (except aspirin, which is to be given as part of standard DVT prophylaxis in all cases).
  • Other drugs that may affect the activity of the drugs under investigation.
  • Allergy to asprin (all patients to receive 150mg aspirin as standard DVT prophylaxis for 6 weeks).
  • Patients with known coagulopathy (APTT or PT outside normal range pre-operatively).
  • Previous reaction or ethical/religious objection to receiving blood products (Quixil contains a derivative of human blood).
  • Pregnancy or breastfeeding.
  • Patients who have a past medical history of thrombo-embolism at any time.
  • Patients who need intravenous fluid administration for greater than 24 hours following operation.
  • Patients who need allogenic blood transfusion within study period.
  • Jehovah's Witnesses, or any other group of patients with ethical objections to receiving blood products.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Blood loss as calculated from change in haematocrit

Collaborators and Investigators

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

Sponsor

Golden Jubilee National Hospital

Investigators

  • Principal Investigator: Jamie S McConnell, MB BCh MRCS, Golden Jubilee National Hospital, NHS Scotland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

June 1, 2006

Primary Completion (Actual)

May 1, 2008

Study Completion (Actual)

May 1, 2008

Study Registration Dates

First Submitted

September 20, 2006

First Submitted That Met QC Criteria

September 20, 2006

First Posted (Estimate)

September 21, 2006

Study Record Updates

Last Update Posted (Estimate)

May 14, 2008

Last Update Submitted That Met QC Criteria

May 13, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GJNH-06-01
  • Eudract number 2006-001299-19

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.

Clinical Trials on Hemorrhage

Clinical Trials on IV Tranexamic acid 10mg/kg pt body weight

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe