The Study on Appropriate Strategy of Transfusion in Cardiovascular Surgery: a multicenter randomized controlled trial.

UMIN ID: UMIN000000691

Registered date:01/05/2007

Basic Information

• Health condition(s) or Problem(s) studied: Patients who undergo thoracic aortic surgery
• Date of first enrollment: 2007/04/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Arm1: liberal strategy Platelet concentrates are transfused if the platelet count drops below 100,000/uL,and platelet counts are maintained at 100,000/uLor more. Cryoprecipitates are transfused if plasma fibrinogen level drops below 150 mg/dL, and plasma fibrinogen levels are maintained at 150 mg/dL or more.
Arm2: restrictive strategy Platelet concentrates are transfused if the platelet count drops below 50,000/uL,and platelet counts are maintained at 50,000/uLor more. Fresh frozen plasmas are transfused if plasma fibrinogen level drops below 150 mg/dL, and plasma fibrinogen levels are maintained at 150 mg/dL or more.

Outcome(s)

• Primary Outcome: Main outcome measures: The total volume of allogeneic red blood cells transfused during the surgery and within 24 hours after the surgery
• Secondary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 90years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: National Cardiovascular Center
• Source(s) of Monetary Support: Japanese Ministry of Health, Labor, and Welfar