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

This study has been completed.
Sponsor:
Information provided by:
Golden Jubilee National Hospital
ClinicalTrials.gov Identifier:
NCT00378872
First received: September 20, 2006
Last updated: May 13, 2008
Last verified: May 2008
  Purpose

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


Condition Intervention
Hemorrhage
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Drug: IV Tranexamic acid 10mg/kg pt body weight
Drug: Quixil topical sealant

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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.

Resource links provided by NLM:


Further study details as provided by Golden Jubilee National Hospital:

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

Enrollment: 132
Study Start Date: June 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Nadler SB, Hidalgo JU, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962;51:224-232.

Additional 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
Study First Received: September 20, 2006
Last Updated: May 13, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

ClinicalTrials.gov processed this record on September 18, 2014