Contact information
Type
Scientific
Primary contact
Dr R J M Klautz
ORCID ID
Contact details
Leiden University Medical Centre (LUMC)
Department of CardioThoracic Surgery
Room D6-53
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 4022
r.j.m.klautz@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR261
Study information
Scientific title
Acronym
TAP Trial: Tranexaminic acid - Aprotinin - Placebo trial
Study hypothesis
We 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 reexposure seen with aprotinin.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Randomised, placebo controlled, parallel group, double blinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Heart surgery, Cardiopulmonary Bypass (CPB), bleeding
Intervention
Group 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 sample preoperative and four blood samples will be taken postoperatively to assess for protein concentrations related to Systemic Inflammatory Response Syndrome (SIRS).
Intervention type
Drug
Phase
Not Specified
Drug names
Aprotinin, tranexaminic acid
Primary outcome measure
1. Intraoperative and perioperative blood loss
2. Intraoperative and perioperative use of blood products
Secondary outcome measures
1. Rethoracotomies
2. The total duration of each patient's stay in the operating room
3. Length of stay in the Intensive Care Unit (ICU) and hospital
4. Development of SIRS/sepsis/Multiple Organ Failure (MOF)
5. 30-day morbidity
6. 30-day mortality
7. Costs
Overall trial start date
31/05/2004
Overall trial end date
31/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients scheduled for first time, non-complex (one or two procedures) open heart surgery with the use of Cardiopulmonary Bypass (CPB).
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. 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 five days of the operation
8. Known bleeding disorder
9. Pregnancy
10. Scheduled for three or more procedures
11. Emergency operations
Recruitment start date
31/05/2004
Recruitment end date
31/08/2006
Locations
Countries of recruitment
Netherlands
Trial participating centre
Leiden University Medical Centre (LUMC)
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Centre (LUMC) (Netherlands)
Sponsor details
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Leiden University Medical Centre (LUMC) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19250838
Publication citations
-
Results
Later AF, Maas JJ, Engbers FH, Versteegh MI, Bruggemans EF, Dion RA, Klautz RJ, Tranexamic acid and aprotinin in low- and intermediate-risk cardiac surgery: a non-sponsored, double-blind, randomised, placebo-controlled trial., Eur J Cardiothorac Surg, 2009, 36, 2, 322-329, doi: 10.1016/j.ejcts.2008.11.038.