Improvement of hemostasis, coagulation and bleeding count with use of fresh frozen plasma for priming of the cardiopulmonary bypass circuits for cardiac surgeries in neonates and infants

UMIN ID: UMIN000054599

Registered date:10/06/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Congenital Heart Diseases
• Date of first enrollment: 2024/06/07
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Use of FFP for priming of the CPB circuits

Outcome(s)

• Primary Outcome: 1) the platelet counts and fibrinogen levels at several time points: cessation of CPB, at cessation of modified ultrafiltration (MUF), after sternum closure and on admission in ICU (intensive care unit) 2) intraoperative transfusion volume 3) intraoperative bleeding count following the cessation of CPB 4) thrombotic complication
• Secondary Outcome: 1) the platelet count and fibrinogen levels on the next day after the surgery 2) transfusion volume during 12 hours after the surgery 3) bleeding count during 12 hours after the surgery 4) length of stay in the ICU 5) postoperative complication and mortality

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: 1years-old
• Gender: Male and Female
• Exclude criteria: cases of written informed consent not obtained from the parent of the patient

Related Information

• Primary Sponsor: Kouki Fukuda Department of Anesthesiology Gifu Prefectural General Medical Center 4-6-1 Noishiki Gifu 500-8717, Japan
• Source(s) of Monetary Support: Gifu Prefectural General Medical Center