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

Hemorrhage Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00378872
• Other study ID #: GJNH-06-01
• Secondary ID: Eudract number 2
• Status: Completed
• Phase: N/A
• First received: September 20, 2006
• Last updated: May 13, 2008
• Start date: June 2006
• Est. completion date: May 2008

Study information

• Verified date: May 2008
• Source: Golden Jubilee National Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

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

Intervention

Drug:
• IV Tranexamic acid 10mg/kg pt body weight

• Quixil topical sealant

Locations

Country	Name	City	State
United Kingdom	Golden Jubilee National Hospital	Clydebank	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Golden Jubilee National Hospital

Country where clinical trial is conducted

United Kingdom, 

References & Publications (9)

Benoni G, Fredin H. Fibrinolytic inhibition with tranexamic acid reduces blood loss and blood transfusion after knee arthroplasty: a prospective, randomised, double-blind study of 86 patients. J Bone Joint Surg Br. 1996 May;78(3):434-40. — View Citation

Hiippala ST, Strid LJ, Wennerstrand MI, Arvela JV, Niemelä HM, Mäntylä SK, Kuisma RP, Ylinen JE. Tranexamic acid radically decreases blood loss and transfusions associated with total knee arthroplasty. Anesth Analg. 1997 Apr;84(4):839-44. — View Citation

Ho KM, Ismail H. Use of intravenous tranexamic acid to reduce allogeneic blood transfusion in total hip and knee arthroplasty: a meta-analysis. Anaesth Intensive Care. 2003 Oct;31(5):529-37. — View Citation

Husted H, Blønd L, Sonne-Holm S, Holm G, Jacobsen TW, Gebuhr P. Tranexamic acid reduces blood loss and blood transfusions in primary total hip arthroplasty: a prospective randomized double-blind study in 40 patients. Acta Orthop Scand. 2003 Dec;74(6):665-9. — View Citation

Levy O, Martinowitz U, Oran A, Tauber C, Horoszowski H. The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study. J Bone Joint Surg Am. 1999 Nov;81(11):1580-8. — View Citation

Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. — View Citation

Sehat KR, Evans RL, Newman JH. Hidden blood loss following hip and knee arthroplasty. Correct management of blood loss should take hidden loss into account. J Bone Joint Surg Br. 2004 May;86(4):561-5. — View Citation

Wang GJ, Hungerford DS, Savory CG, Rosenberg AG, Mont MA, Burks SG, Mayers SL, Spotnitz WD. Use of fibrin sealant to reduce bloody drainage and hemoglobin loss after total knee arthroplasty: a brief note on a randomized prospective trial. J Bone Joint Surg Am. 2001 Oct;83-A(10):1503-5. — View Citation

Zohar E, Fredman B, Ellis M, Luban I, Stern A, Jedeikin R. A comparative study of the postoperative allogeneic blood-sparing effect of tranexamic acid versus acute normovolemic hemodilution after total knee replacement. Anesth Analg. 1999 Dec;89(6):1382-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood loss as calculated from change in haematocrit