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Decreasing Hemorrhage Risk in Children With Alagille Syndrome
Recruiting
Trial ID: NCT05846854
Purpose
The goal of this interventional study is to test a hemostasis screening protocol and cardiac
peri-procedural and post-operative hemostasis pathway to improving bleeding complications and
improve patient survival for children with Alagille syndrome and complex cardiac conditions.
The main questions it aims to answer are:
- Are children with Alagille syndrome with cardiac anomalies more likely to have acquired
von Willebrand syndrome (a condition that causes increased bleeding)
- Does implementation of a novel screening protocol to detect pre-operative bleeding
conditions decrease intra-operative and/or post-operative bleeding complications and
mortality risk?
- Does implementation of a novel screening protocol to detect and treat bleeding
conditions cause thrombotic complications?
Participants will undergo additional hematology and bleeding disorder screening prior to
cardiac surgery. They will additionally undergo a detailed family screening for a history of
bleeding by a genetic counselor.
Researchers will compare these findings with children who have similar complex cardiac
conditions requiring surgery, but who do not have Alagille syndrome to see if bleeding
conditions and complications are more or less common in children with Alagille syndrome.
Official Title
Novel Protocol to Decrease Peri-procedural and Intra-operative Hemorrhage in Children With Alagille Syndrome
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- 0-17 years old
- with complex cardiac condition requiring pulmonary artery reconstruction (branch
pulmonary artery stenosis, MAPCAs or Tetralogy of Fallot without MAPCAs)
Exclusion Criteria:
- history of known bleeding disorder
- aged 18 years or older
Intervention(s):
other: Assessment for bleeding disorder with tailored post-operative care
Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305