Tranexamic Acid vs. Quixil - Reducing Blood Loss in Joint Replacement
NCT ID: NCT00378872
Last Updated: 2008-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2006-06-30
2008-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Interventions
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IV Tranexamic acid 10mg/kg pt body weight
Quixil topical sealant
Eligibility Criteria
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Inclusion Criteria
* Must be cemented arthroplasty
* Must be primary arthroplasty
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Golden Jubilee National Hospital
OTHER_GOV
Responsible Party
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Golden Jubilee National Hospital
Principal Investigators
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Jamie S McConnell, MB BCh MRCS
Role: PRINCIPAL_INVESTIGATOR
Golden Jubilee National Hospital, NHS Scotland
Locations
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Golden Jubilee National Hospital
Clydebank, Scotland, United Kingdom
Countries
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References
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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.
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. doi: 10.1097/00000539-199704000-00026.
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. doi: 10.1177/0310057X0303100507.
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. doi: 10.1080/00016470310018171.
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. doi: 10.2106/00004623-199911000-00010.
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
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(10):1503-5. doi: 10.2106/00004623-200110000-00007.
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. doi: 10.1097/00000539-199912000-00010.
McConnell JS, Shewale S, Munro NA, Shah K, Deakin AH, Kinninmonth AW. Reduction of blood loss in primary hip arthroplasty with tranexamic acid or fibrin spray. Acta Orthop. 2011 Dec;82(6):660-3. doi: 10.3109/17453674.2011.623568. Epub 2011 Oct 17.
McConnell JS, Shewale S, Munro NA, Shah K, Deakin AH, Kinninmonth AW. Reducing blood loss in primary knee arthroplasty: a prospective randomised controlled trial of tranexamic acid and fibrin spray. Knee. 2012 Aug;19(4):295-8. doi: 10.1016/j.knee.2011.06.004. Epub 2011 Jul 5.
Other Identifiers
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Eudract number 2006-001299-19
Identifier Type: -
Identifier Source: secondary_id
GJNH-06-01
Identifier Type: -
Identifier Source: org_study_id