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The Tranexaminic acid - Aprotinin - Placebo trial.


- candidate number1447
- NTR NumberNTR261
- ISRCTNISRCTN00157697
- Date ISRCTN created20-dec-2005
- date ISRCTN requested18-okt-2005
- Date Registered NTR7-sep-2005
- Secondary IDsN/A 
- Public TitleThe Tranexaminic acid - Aprotinin - Placebo trial.
- Scientific TitleThe clinical and economic effectiveness of High-dose aprotinin and tranexamic acid in patients undergoing first time open-heart surgery. a single-centre, double blind, prospective, randomised, placebo-controlled trial.
- ACRONYMTAP Trial
- hypothesisWe expect that aprotinin will be better in reducing blood loss and transfusion requirements compared with tranexamic acid. However, tranexamic acid will be more cost effective and avoid the risk of anaphylactic shock at reexposeure seen with aprotinin.
- Healt Condition(s) or Problem(s) studiedBlood transfusions, Heart surgery, Cardiopulmonary Bypass (CPB), Blood loss
- Inclusion criteriaPatients scheduled for first time, non-complex (one or two procedures) open heart surgery with the use of CPB.
- Exclusion criteria1. Less than 18 years old;
2. Previous sternotomy;
3. Previous aprotinin therapy;
4. Known or suspected allergy to aprotinin;
5. Refusal to receive blood transfusion;
6. Abnormal perioperative coagulation profile for reasons other than anticoagulant therapy;
7. Treatment with antiplatelet agents within the 5 days before the operation;
8. Known bleeding disorder;
9. Pregnancy;
10. Scheduled for 3 or more procedures;
11. Emergency operations.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 31-mei-2004
- planned closingdate31-aug-2006
- Target number of participants300
- InterventionsGroup A will receive placebo;
Group B will receive high dose aprotinin;
Group C will receive tranexamic acid.
- All medications will be administered during surgery. Anesthetic and surgical procedures in all groups will be carried out according to standard care ;
- All patients will be observed until their discharge, during which time all measurements obtained during standard care will be recorded;
- One blood monster preoperative and four blood monsters will be taken postoperatively to asses for protein concentrations related to SIRS.
- Primary outcome1. Intraoperative and perioperative blood loss;
2. Intraoperative and perioperative use of blood products.
- Secondary outcome1. Rethoracotomies;
2. The total duration of each patient's stay in the operating room;
3. Length of stay in the ICU and hospital;
4. Development of SIRS/sepsis/MOF;
5. 30-day morbidity;
6. 30-day mortality;
7. Costs.
- TimepointsN/A
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIESDr. R.J.M. Klautz
- CONTACT for SCIENTIFIC QUERIESDr. R.J.M. Klautz
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryBleeding and the need foor blood transfusions are correlated with increased morbidity, mortality and higher costs. Aprotinin and tranexamic acid have shown to reduce borh blood loss and transfusion requirements during and after cardiac surgery. The efficacy and cost effectivity of tranexamic acid in comparison to aprotinin has been minimally investigated. The few controlled clinical trials that have been performed show a slight benefit of aprotinin over tranexamic acid.
The purpose of this study is to determine which of these pharmacological agents is most efficious and cost effective compared to standard treatment.
- Main changes (audit trail)
- RECORD7-sep-2005 - 2-dec-2008


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