HemorrhageNCT00378872
Tranexamic Acid vs. Quixil - Reducing Blood Loss in Joint Replacement
A study testing IV Tranexamic acid 10mg/kg pt body weight and Quixil topical sealant in people with Hemorrhage and Arthroplasty, Replacement, Hip, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
Trial summary
We will compare the effectiveness of Quixil and Tranexamic acid in reducing bleeding during hip and knee joint replacements. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemorrhage, Arthroplasty, Replacement, Hip, Arthroplasty, Replacement, Knee
- What is being tested?
- IV Tranexamic acid 10mg/kg pt body weight and Quixil topical sealant
- Type of treatment
- Injection or infusion
- How many people
- 132 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients who are to undergo elective hip or knee joint replacement
- Must be cemented arthroplasty
- Must be primary arthroplasty
Who cannot join
- 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).
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Golden Jubilee National Hospital
Clydebank, Scotland, G81 4HX
About this study
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.
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.
- Being tested
- IV Tranexamic acid 10mg/kg pt body weight, Quixil topical sealant
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Tranexamic acid 10mg/kg pt body weightDrug
Quixil topical sealantDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss as calculated from change in haematocrit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJun 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Golden Jubilee National Hospital
- Sponsor type
- Other government
- Investigators
- Jamie S McConnell, MB BCh MRCS, Principal investigator, Golden Jubilee National Hospital, NHS Scotland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378872
- Sponsor's protocol ID
- GJNH-06-01
- Other IDs
- Eudract number 2006-001299-19
- Status last verified
- May 2008
- First submitted
- 20 Sep 2006
- Last updated
- 14 May 2008
- Results posted
- No
- Data monitoring committee
- No
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 8636182Hiippala 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 9085968Ho 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 14601276Husted 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 14763696Levy 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 10565650Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
PubMed 21936146Sehat 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 15174554Wang 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 11679600Zohar 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 10589612McConnell 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 21999623McConnell 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
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00378872
- Acronym / sponsor ID
- GJNH-06-01
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Golden Jubilee National HospitalOther government
- Study start
- Jun 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who are to undergo elective hip or knee joint replacement
- Must be cemented arthroplasty
- Must be primary arthroplasty
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Tranexamic acid 10mg/kg pt body weight | Drug | – |
| Quixil topical sealant | Drug | – |
Primary outcome
Blood loss as calculated from change in haematocrit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2008.
- Background: PubMed 8636182Benoni 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.
- Background: PubMed 9085968Hiippala 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.
- Background: PubMed 14601276Ho 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.
- Background: PubMed 14763696Husted 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.
- Background: PubMed 10565650Levy 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.
- Background: PubMed 21936146Nadler SB, Hidalgo JH, Bloch T. Prediction of blood volume in normal human adults. Surgery. 1962 Feb;51(2):224-32. No abstract available.
- Background: PubMed 15174554Sehat 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.
- Background: PubMed 11679600Wang 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.
- Background: PubMed 10589612Zohar 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.
- Derived from this study: PubMed 21999623McConnell 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.
- Derived from this study: PubMed 21733697McConnell 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie S McConnell, MB BCh MRCS principal investigator
Golden Jubilee National Hospital, NHS Scotland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IV Tranexamic acid 10mg/kg pt body weight and Quixil topical sealant in people with Hemorrhage and Arthroplasty, Replacement, Hip, run by Golden Jubilee National Hospital at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss as calculated from change in haematocrit. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00378872, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2008.