ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00378872
Recruitment Status : Completed
First Posted : September 21, 2006
Last Update Posted : May 14, 2008
Sponsor:
Information provided by:
Golden Jubilee National Hospital

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

Condition or disease Intervention/treatment Phase
Hemorrhage Arthroplasty, Replacement, Hip Arthroplasty, Replacement, Knee Drug: IV Tranexamic acid 10mg/kg pt body weight Drug: Quixil topical sealant Not Applicable

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  (Clinical Trial)
Actual Enrollment : 132 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Prospective Randomised Trial Comparing Intraoperative Topical Quixil and Intravenous Tranexamic Acid, in Reduction of Blood Loss Following Primary Hip & Knee Joint Replacement Surgery.
Study Start Date : June 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding




Primary Outcome Measures :
  1. Blood loss as calculated from change in haematocrit


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378872


Locations
United Kingdom
Golden Jubilee National Hospital
Clydebank, Scotland, United Kingdom, G81 4HX
Sponsors and Collaborators
Golden Jubilee National Hospital
Investigators
Principal Investigator: Jamie S McConnell, MB BCh MRCS Golden Jubilee National Hospital, NHS Scotland

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr Andrew Kinninmonth, Golden Jubilee National Hospital
ClinicalTrials.gov Identifier: NCT00378872     History of Changes
Other Study ID Numbers: GJNH-06-01
Eudract number 2006-001299-19
First Posted: September 21, 2006    Key Record Dates
Last Update Posted: May 14, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Tranexamic Acid
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants