Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Tranexamico/2002
Study information
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
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 measure
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 (if study stopped)
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
Total final enrolment
50
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
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
Basic results (scientific)
Publication list
2007 results in https://pubmed.ncbi.nlm.nih.gov/17988379/ (added 05/01/2021)