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
Completed
- Conditions
- Systemic inflammatory response syndromeNot Applicable
- Registration Number
- ISRCTN05718824
- Lead Sponsor
- niversity Hospital of Canary Islands (Consorcio Sanitario de Tenerife [CST]) (Spain)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Consecutive Caucasian adults undergoing elective cardiopulmonary bypass surgery with normal aggregation and coagulation test values.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the efficacy of tranexamic acid in decreasing the incidence of systemic inflammatory response syndrome and postoperative bleeding.<br><br>Data was recorded preoperatively, after surgery, at Intensive Care Unit admission (0 hours), four hours and 24 hours.
- Secondary Outcome Measures
Name Time Method 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.<br><br>Data was recorded preoperatively, after surgery, at Intensive Care Unit admission (0 hours), four hours and 24 hours.