The Study on Appropriate Strategy of Transfusion in Cardiovascular Surgery: a multicenter randomized controlled trial.
Phase 2
- Conditions
- Patients who undergo thoracic aortic surgery
- Registration Number
- JPRN-UMIN000000691
- Lead Sponsor
- ational Cardiovascular Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
The Patient has a congenital bleeding tendency The patient has chronic thrombocytopenia (defined as a platelet count <100,000/uL for more than 30 days) The patient has anemia (defined as a hemoglobin level <8.0g/dL) The patient possesses an anti-HLA or anti-platelet antibody, resulting in platelet refractoriness It is highly possible to complete the surgery of the patient without any transfusion in the judgement of the investigator. The patient is inappropriate for entry onto this study in the judgment of the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main outcome measures: The total volume of allogeneic red blood cells transfused during the surgery and within 24 hours after the surgery
- Secondary Outcome Measures
Name Time Method Other outcome measures: The total volume of mediastinal drainage during the first 12 hours or the first 24 hours in the ICU, re-exploration for bleeding, duration of time in the operating room after CPB, length of stay in ICU and hospital, hospital death, one-year survival, morbidity (e.g., renal failure, liver dysfunction, infection, heart failure, MI, neurological dysfunction, thromboembolic events), the total amount of each blood component transfused during hospitalization, the value of hemoglobin, platelet count, fibrinogen, prothrombin time, or activated partial thromboplastin time just prior to transfusion of each blood component, and the total medical cost.