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

NCT00378872 | Completed

• 2 other identifiers: GJNH-06-01Eudract number 2006-001299-19
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Blood loss as calculated from change in haematocrit

Interventions

IV Tranexamic acid 10mg/kg pt body weight DRUG

Quixil topical sealant DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are to undergo elective hip or knee joint replacement
• Must be cemented arthroplasty
• Must be primary arthroplasty

You may not qualify if:

• 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.

Sponsors & Collaborators

• Golden Jubilee National Hospital: lead

Study Sites (1)

Golden Jubilee National Hospital

Clydebank, Scotland, G81 4HX, United Kingdom

Location

Related Publications (11)

• 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.

  PMID: 8636182 BACKGROUND

• 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.

  PMID: 9085968 BACKGROUND

• 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.

  PMID: 14601276 BACKGROUND

• 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.

  PMID: 14763696 BACKGROUND

• 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.

  PMID: 10565650 BACKGROUND

• Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.

  PMID: 21936146 BACKGROUND

• 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.

  PMID: 15174554 BACKGROUND

• 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.

  PMID: 11679600 BACKGROUND

• 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.

  PMID: 10589612 BACKGROUND

• 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.

  PMID: 21999623 DERIVED

• 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.

  PMID: 21733697 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Jamie S McConnell, MB BCh MRCS

  Golden Jubilee National Hospital, NHS Scotland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 20, 2006
• First Posted: September 21, 2006
• Study Start: June 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: May 14, 2008

Record last verified: 2008-05

Locations

GB (1)