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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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05718824
Enrollment
100
Registered
2007-05-18
Start date
2002-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic inflammatory response syndrome Not Applicable Systemic inflammatory response syndrome

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 dischar

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026