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

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

Detailed Description
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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.

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

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

Intervention / Treatment
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* Drug: IV Tranexamic acid 10mg/kg pt body weight
* Drug: Quixil topical sealant


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IV Tranexamic acid 10mg/kg pt body weight|nan|
|Drug: Quixil topical sealant|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss as calculated from change in haematocrit |  |  |