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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
IV Tranexamic acid 10mg/kg pt body weight
Quixil topical sealant
Sponsored by
Golden Jubilee National Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hemorrhage

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Golden Jubilee National Hospital

Outcomes

Primary Outcome Measures

Blood loss as calculated from change in haematocrit

Secondary Outcome Measures

Full Information

First Posted
September 20, 2006
Last Updated
May 13, 2008
Sponsor
Golden Jubilee National Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00378872
Brief Title
Tranexamic Acid vs. Quixil - Reducing Blood Loss in Joint Replacement
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.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2008
Overall Recruitment Status
Completed
Study Start Date
June 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Golden Jubilee National Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhage, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
IV Tranexamic acid 10mg/kg pt body weight
Intervention Type
Drug
Intervention Name(s)
Quixil topical sealant
Primary Outcome Measure Information:
Title
Blood loss as calculated from change in haematocrit

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jamie S McConnell, MB BCh MRCS
Organizational Affiliation
Golden Jubilee National Hospital, NHS Scotland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Golden Jubilee National Hospital
City
Clydebank
State/Province
Scotland
ZIP/Postal Code
G81 4HX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
8636182
Citation
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.
Results Reference
background
PubMed Identifier
9085968
Citation
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.
Results Reference
background
PubMed Identifier
14601276
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. doi: 10.1177/0310057X0303100507.
Results Reference
background
PubMed Identifier
14763696
Citation
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.
Results Reference
background
PubMed Identifier
10565650
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. doi: 10.2106/00004623-199911000-00010.
Results Reference
background
PubMed Identifier
21936146
Citation
Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
Results Reference
background
PubMed Identifier
15174554
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.
Results Reference
background
PubMed Identifier
11679600
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(10):1503-5. doi: 10.2106/00004623-200110000-00007.
Results Reference
background
PubMed Identifier
10589612
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. doi: 10.1097/00000539-199912000-00010.
Results Reference
background
PubMed Identifier
21999623
Citation
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.
Results Reference
derived
PubMed Identifier
21733697
Citation
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.
Results Reference
derived

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

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