The goal of the study is to determine whether the use of Human Fibrinogen Concentrate (RiaSTAP) will decrease blood loss and the need for component blood therapy in neonates and infants undergoing cardiopulmonary bypass.
Age range
1 Day – 1 Year
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Postoperative Blood Loss After Surgery (Estimated Blood Loss (EBL))
Timeframe: Within 24 hours of surgery
Post-operative 2 hr Hemoglobin (Hg) mg/dL Measure
Timeframe: 2 hour
Post-operative 24-hr Hemoglobin (Hg) mg/dL
Timeframe: 24 hr
Post-operative 2 hr Hematocrit (HCT) Measure
Timeframe: 2 hour
Post-operative 24 hr Hematocrit (HCT) Measure
Timeframe: 24 hour
Post-operative 2 hr Platelets Count Test (PLT) 10K/uL
Timeframe: 2 hour
Post-operative 24 hr Platelets Count Test (PLT) 10K/uL
Timeframe: 24 hour
Post-operative 2 hr Prothrombin (PT) Seconds
Timeframe: 2 hour
Post-operative 24 hr Prothrombin (PT) Seconds
Timeframe: 24 hour
Post-operative 2 hr International Normalize Ratio (INR)
Timeframe: 2 hour
Post-operative 24 hr International Normalize Ratio (INR)
Timeframe: 24 hour
Post-operative 2 hr Partial Thromboplastin Time (PTT) Seconds
Timeframe: 2 hour
Post-operative 24 hr Partial Thromboplastin Time (PTT) Seconds
Timeframe: 24 hour
Post-operative 2 hr Fibrinogen mg/dL
Timeframe: 2 hour
Post-operative 24 hr Fibrinogen mg/dL
Timeframe: 24 hour