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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN84413719

Enrollment

160

Registered

2009-07-15

Start date

2005-12-01

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 (SIRS), post-operative bleeding Injury, Occupational Diseases, Poisoning Complications of procedures, not elsewhere classified

Interventions

Patients were randomly assigned by independent pharmacists using a list of pseudo-randomised numbers to receive coded infusions of either tranexamic acid (TA) (40 mg/kg pre-CPB and 40 mg/kg post-CPB)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Equal or older than 18 years old, either sex 2. Elective cardiopulmonary bypass surgery 3. Informed consent approval

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 2. Mortality, measured from the first 24 hours after surgery up to ICU discharge 3. Mechanical ventilation time, measured from the first 24 hours after surgery up to ICU discharge 4. Vasopressor requirements, measured from the first 24 hours after surgery up to ICU discharge 5. ICU length of stay, measured from the first 24 hours after surgery up to ICU discharge	—

Measure

Time frame

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 2. Mortality, measured from the first 24 hours after surgery up to ICU discharge 3. Mechanical ventilation time, measured from the first 24 hours after surgery up to ICU discharge 4. Vasopressor requirements, measured from the first 24 hours after surgery up to ICU discharge 5. ICU length of stay, measured from the first 24 hours after surgery up to ICU discharge

—

Countries

Spain

Outcome results

None listed

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