Randomised, double-blind, controlled study of the tranexamic acid prophylaxis efficacy on the development of systemic inflammatory response syndrome and postoperative bleeding in cardiopulmonary bypass surgery patients

ISRCTN	ISRCTN05718824
DOI	https://doi.org/10.1186/ISRCTN05718824
Protocol serial number	Tranexamico/2002
Sponsor	University Hospital of Canary Islands (Consorcio Sanitario de Tenerife [CST]) (Spain)
Funder	Canary Islands Foundation of Health Research (Fundación Canaria de Investigación y Salud [FUNCIS]) (Spain) (ref: 2202)

Submission date: 21/03/2007
Registration date: 18/05/2007
Last edited: 05/01/2021

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Jose Luis Iribarren
Scientific

Ofra s/n
La Laguna
38320
Spain

Study information

Primary study design	Interventional
Study design	Randomised, double-blind, controlled study
Secondary study design	Randomised controlled trial
Scientific title	Randomised, double-blind, controlled study of the tranexamic acid prophylaxis efficacy on the development of systemic inflammatory response syndrome and postoperative bleeding in cardiopulmonary bypass surgery patients
Study acronym	TX/02
Study objectives	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(s)	Approval received from the University Hospital of Canary Islands Ethics and Research Council on the 20th December 2001 (ref: 35/01).
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Tranexamic acid, protamine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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.
Completion date	01/09/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	100
Total final enrolment	50
Key inclusion criteria	Consecutive Caucasian adults undergoing elective cardiopulmonary bypass surgery with normal aggregation and coagulation test values.
Key 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
Date of first enrolment	01/06/2002
Date of final enrolment	01/09/2003

Locations

Countries of recruitment

Spain

Study participating centre

Ofra s/n

La Laguna
38320
Spain

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	01/08/2007	05/01/2021	Yes	No

Editorial Notes

05/01/2021: Publication reference and total final enrolment added.