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

Sponsored by:	Golden Jubilee National Hospital
Information provided by:	Golden Jubilee National Hospital
ClinicalTrials.gov Identifier:	NCT00378872

Purpose

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

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

MedlinePlus related topics: Knee Replacement

Drug Information available for: Tranexamic acid

U.S. FDA Resources

Study Type:

Interventional

Study Design:

Active Control, Parallel Assignment, Prevention, Randomized, Safety/Efficacy Study, Single Blind

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00378872

Locations

United Kingdom, Scotland
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.

Hiippala ST, Strid LJ, Wennerstrand MI, Arvela JV, Niemela HM, Mantyla 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.

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.

Husted H, Blond 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.

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.

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.

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.

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.

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.

Responsible Party:	Golden Jubilee National Hospital ( Mr Andrew Kinninmonth )
Study ID Numbers:	GJNH-06-01, Eudract number 2006-001299-19
Study First Received:	September 20, 2006
Last Updated:	May 13, 2008
ClinicalTrials.gov Identifier:	NCT00378872 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Fibrin Modulating Agents
Antiplasmin
Antifibrinolytic Agents

Tranexamic Acid
Hemorrhage
Hemostatics

Additional relevant MeSH terms:

Fibrin Modulating Agents
Antifibrinolytic Agents
Pathologic Processes
Coagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Hematologic Agents
Tranexamic Acid
Hemorrhage
Hemostatics
Pharmacologic Actions

ClinicalTrials.gov processed this record on March 16, 2009