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CompletedNCT00378872Updated May 14, 2008

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

An interventional study of IV Tranexamic acid 10mg/kg pt body weight and Quixil topical sealant in Hemorrhage, Arthroplasty, Replacement, Hip and Arthroplasty, Replacement, Knee, sponsored by Golden Jubilee National Hospital. Completed at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2008-05-14.

Sponsored by Golden Jubilee National Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
132
Allocation
Randomized
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

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

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03

In context

Hemorrhage

3,000 studies on the registry are indexed under Hemorrhage; 474 are open to participants now.

This study's enrollment of 132 is above the median of 100 across 1,985 interventional studies indexed under Hemorrhage.

Browse Hemorrhage studies →

Lead sponsor

Golden Jubilee National Hospital is the lead sponsor of 28 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single
Enrollment
132 participants (actual)

Interventions

  • DrugIV Tranexamic acid 10mg/kg pt body weight
  • DrugQuixil topical sealant
06

What researchers measure

Primary outcomes

  1. Blood loss as calculated from change in haematocrit

07

Study locations

1 site
  • Golden Jubilee National Hospital
    Clydebank, Scotland G81 4HX, United Kingdom
08

References and documents

Publications

  • 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. PubMed 8636182 ↗
  • 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. PubMed 9085968 ↗
  • 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. PubMed 14601276 ↗
  • 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. PubMed 14763696 ↗
  • 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. PubMed 10565650 ↗
  • Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available. PubMed 21936146 ↗
  • 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. PubMed 15174554 ↗
  • 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. PubMed 11679600 ↗
  • 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. PubMed 10589612 ↗
  • 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. PubMed 21999623 ↗
  • 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. PubMed 21733697 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00378872
Lead sponsor
Golden Jubilee National Hospital
First posted
Sep 21, 2006
Start date
Jun 2006
Primary completion
May 2008
Completion
May 2008
Last update
May 14, 2008

Study contacts

Jamie S McConnell, MB BCh MRCS
principal investigator · Golden Jubilee National Hospital, NHS Scotland

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2008. You cannot join it, but the record below documents what was studied.

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