ISRCTN84413719
Completed
Not Applicable
Randomised double-blind phase IV clinical trial on 24 hours duration of various groups of tranexamic acid treatment on the effectiveness in the prevention of systemic inflammatory response syndrome and post-operative bleeding in elective cardiopulmonary bypass patients
Hospital Universitario de Canarias (Spain)0 sites160 target enrollmentJuly 15, 2009
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Systemic inflammatory response syndrome (SIRS), post-operative bleeding
- Sponsor
- Hospital Universitario de Canarias (Spain)
- Enrollment
- 160
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Equal or older than 18 years old, either sex
- •2\. Elective cardiopulmonary bypass surgery
- •3\. Informed consent approval
Exclusion Criteria
- •1\. Younger than 18 years old
- •2\. Tranexamic acid hypersensibility
- •3\. Gross haematuria
- •4\. Emergency interventions
- •5\. Off\-pump cardiac surgery
- •6\. Patients with a history of:
- •6\.1\. Chronic coagulopathy (prothrombin time \[PT] of less than 50% or international normalised ratio of greater than 2 and platelets of less than 50,000/mm^3 or aggregation dysfunction)
- •6\.2\. Renal failure (creatinine of greater than 2 mg/dl)
- •6\.3\. Chronic hepatopathy (Child B or higher degree)
- •6\.4\. Use of immunosuppressant drugs
Outcomes
Primary Outcomes
Not specified
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