Welcome
Support Centre
23 September 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
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 10.1186/ISRCTN05718824
ClinicalTrials.gov identifier
EudraCT number
Public 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
Scientific title
Acronym TX/02
Serial number at source Tranexamico/2002
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.
Lay summary
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
Countries of recruitment Spain
Disease/condition/study domain Systemic inflammatory response syndrome
Participants - inclusion criteria Consecutive Caucasian adults undergoing elective cardiopulmonary bypass surgery with normal aggregation and coagulation test values.
Participants - 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
Anticipated start date 01/06/2002
Anticipated end date 01/09/2003
Status of trial Completed
Patient information material
Target number of participants 100
Interventions 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.
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.
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.
Sources of funding Canary Islands Foundation of Health Research (Fundación Canaria de Investigación y Salud [FUNCIS]) (Spain) (ref: 2202)
Trial website
Publications
Contact name Dr  Jose Luis  Iribarren
  Address Ofra s/n
  City/town La Laguna
  Zip/Postcode 38320
  Country Spain
Sponsor University Hospital of Canary Islands (Consorcio Sanitario de Tenerife [CST]) (Spain)
  Address c/o Juan José Jiménez Rivera
Ofra s/n
  City/town La Laguna
  Zip/Postcode 38320
  Country Spain
  Sponsor website: http://www.hecit.es/index.html
Date applied 21/03/2007
Last edited 21/09/2007
Date ISRCTN assigned 18/05/2007
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.