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Completed

NCT Number: NCT00378872

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Golden Jubilee National Hospital

Clydebank, Scotland, G81 4HX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IV Tranexamic acid 10mg/kg pt body weight

Drug

Quixil topical sealant

Drug

Primary outcomes

  1. Blood loss as calculated from change in haematocrit

Sponsors and collaborators

Lead sponsor

Golden Jubilee National Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 21, 2006
Registry last updated
May 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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