Condition category
Surgery
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
04/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.lumc.nl/

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

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19250838

Publication citations

  1. 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.

Additional files

Editorial Notes