The 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

ISRCTN	ISRCTN00157697
DOI	https://doi.org/10.1186/ISRCTN00157697
Secondary identifying numbers	NTR261

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 04/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R J M Klautz
Scientific

Leiden University Medical Centre (LUMC)
Department of CardioThoracic Surgery
Room D6-53
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 526 4022
Email	r.j.m.klautz@lumc.nl

Study information

Study design	Randomised, placebo controlled, parallel group, double blinded trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	TAP Trial: Tranexaminic acid - Aprotinin - Placebo trial
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	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 study start date	31/05/2004
Completion date	31/08/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	300
Key inclusion criteria	Patients scheduled for first time, non-complex (one or two procedures) open heart surgery with the use of Cardiopulmonary Bypass (CPB).
Key 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
Date of first enrolment	31/05/2004
Date of final enrolment	31/08/2006

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Centre (LUMC)

Leiden
2300 RC
Netherlands

Sponsor information

Leiden University Medical Centre (LUMC) (Netherlands)
University/education

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Website	http://www.lumc.nl/
"ROR"	https://ror.org/027bh9e22

Funders

Funder type

Hospital/treatment centre

Leiden University Medical Centre (LUMC) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/08/2009		Yes	No