The effectiveness of various groups of 24-hour tranexamic acid treatment in the prevention of systemic inflammatory response syndrome and post-operative bleeding in elective cardiopulmonary bypass patients

Completed

Conditions: Systemic inflammatory response syndrome (SIRS), post-operative bleeding
Injury, Occupational Diseases, Poisoning
Complications of procedures, not elsewhere classified

Registration Number: ISRCTN84413719

Lead Sponsor: Hospital Universitario de Canarias (Spain)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 160

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
6.5. Endocarditis, sepsis in the first 24 hours after intervention, or
6.6. Unwillingness to enrol
6.7. Use of anti-inflammatory agents such as corticosteroids or non-steroidal anti-inflammatory agents, on the previous 5 days before intervention

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Biochemical determinations and haemodynamics parameters, recorded before intervention (baseline), on admission to the ICU after surgery (0 hours), and at 4 hours, 12 hours and 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
1. Blood loss, measured by tube chest drainage and the amount of haemoderivatives used, as well as its frequency, collected after intervention on admission to the ICU after surgery (0 hours), and at 4 hours, 12 hours and 24 hours after surgery, and when chest tubes were removed<br>2. Mortality, measured from the first 24 hours after surgery up to ICU discharge<br>3. Mechanical ventilation time, measured from the first 24 hours after surgery up to ICU discharge<br>4. Vasopressor requirements, measured from the first 24 hours after surgery up to ICU discharge<br>5. ICU length of stay, measured from the first 24 hours after surgery up to ICU discharge