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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00378872

Enrollment

132

Registered

2006-09-21

Start date

2006-06-30

Completion date

2008-05-31

Last updated

2008-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee, Hemorrhage

Brief summary

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

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.

Interventions

DRUGIV Tranexamic acid 10mg/kg pt body weight

DRUGQuixil topical sealant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Blood loss as calculated from change in haematocrit	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 28, 2026