Condition category
Not Applicable
Date applied
21/03/2007
Date assigned
18/05/2007
Last edited
21/09/2007
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 Jose Luis Iribarren

ORCID ID

Contact details

Ofra s/n
La Laguna
38320
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Tranexamico/2002

Study information

Scientific title

Acronym

TX/02

Study hypothesis

We hypothesised that the inhibition of fibrinolysis through the administration of tranexamic acid could reduce the incidence of systemic inflammatory response syndrome and postoperative bleeding after cardiopulmonary bypass.

Ethics approval

Approval received from the University Hospital of Canary Islands Ethics and Research Council on the 20th December 2001 (ref: 35/01).

Study design

Randomised, double-blind, controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Systemic inflammatory response syndrome

Intervention

Infusions of either tranexamic acid or placebo (0.9% saline), with doses of 2 g pre- and post-cardiopulmonary bypass after protamine administration.

Follow-up continued until the patient was discharged from the hospital.

Intervention type

Drug

Phase

Not Specified

Drug names

Tranexamic acid, protamine

Primary outcome measures

To investigate the efficacy of tranexamic acid in decreasing the incidence of systemic inflammatory response syndrome and postoperative bleeding.

Data was recorded preoperatively, after surgery, at Intensive Care Unit admission (0 hours), four hours and 24 hours.

Secondary outcome measures

To investigate the efficacy of tranexamic acid to reduce excessive postoperative bleeding in patients undergoing cardiac surgery, according to the presence of different genotypes of the Plasminogen Activator Inhibitor (PAI-1) gene.

Data was recorded preoperatively, after surgery, at Intensive Care Unit admission (0 hours), four hours and 24 hours.

Overall trial start date

01/06/2002

Overall trial end date

01/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Consecutive Caucasian adults undergoing elective cardiopulmonary bypass surgery with normal aggregation and coagulation test values.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Emergency interventions
2. Patients with a history of haemostatic dysfunction
3. Renal failure (creatinine greater than 2 mg/dL)
4. Chronic hepatopathy
5. Immunodepressed patients
6. Sepsis

Recruitment start date

01/06/2002

Recruitment end date

01/09/2003

Locations

Countries of recruitment

Spain

Trial participating centre

Ofra s/n
La Laguna
38320
Spain

Sponsor information

Organisation

University Hospital of Canary Islands (Consorcio Sanitario de Tenerife [CST]) (Spain)

Sponsor details

c/o Juan José Jiménez Rivera
Ofra s/n
La Laguna
38320
Spain

Sponsor type

Hospital/treatment centre

Website

http://www.hecit.es/index.html

Funders

Funder type

Research organisation

Funder name

Canary Islands Foundation of Health Research (Fundación Canaria de Investigación y Salud [FUNCIS]) (Spain) (ref: 2202)

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

Publication citations

Additional files

Editorial Notes