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Tailored Hemostasis Management for Alagille Syndrome

N/A
Waitlist Available
Led By Noelle Ebel, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
0-17 years old with complex cardiac condition requiring pulmonary artery reconstruction (branch pulmonary artery stenosis, MAPCAs or Tetralogy of Fallot without MAPCAs)
Be younger than 18 years old
Must not have
History of known bleeding disorder
Aged 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up intra-operatively through 30 days post-operatively
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a screening protocol and hemostasis pathway to reduce bleeding complications and improve patient survival for children with Alagille syndrome and complex heart conditions.

Who is the study for?
This trial is for children aged 0-17 with Alagille syndrome and complex heart conditions needing pulmonary artery reconstruction. It's not open to those who already have a known bleeding disorder or are 18 years or older.
What is being tested?
The study tests if a new screening protocol can spot bleeding disorders like von Willebrand syndrome before heart surgery, reducing bleeding risks and death in kids with Alagille syndrome compared to those without it.
What are the potential side effects?
While the trial focuses on screening rather than medication, potential side effects may include complications from blood draws or stress related to additional testing procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 17 or younger with a heart condition needing surgery on my lung arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a known bleeding disorder.
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~intra-operatively through 30 days post-operatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and intra-operatively through 30 days post-operatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Incidence of thromboembolism events in patients with hematologic condition

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: No history of Alagille syndromeExperimental Treatment1 Intervention
Patients with complex cardiac conditions requiring cardiothoracic surgery who do not have a diagnosis of Alagille syndrome.
Group II: Alagille syndromeExperimental Treatment1 Intervention
Patients with complex cardiac conditions requiring cardiothoracic surgery who also have a history of Alagille syndrome.

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,475 Previous Clinical Trials
17,501,443 Total Patients Enrolled
1 Trials studying Alagille Syndrome
25 Patients Enrolled for Alagille Syndrome
Alagille Syndrome AllianceUNKNOWN
Noelle Ebel, MDPrincipal InvestigatorStanford University

Media Library

Assessment for bleeding disorder with tailored post-operative care Clinical Trial Eligibility Overview. Trial Name: NCT05846854 — N/A
Alagille Syndrome Research Study Groups: Alagille syndrome, No history of Alagille syndrome
Alagille Syndrome Clinical Trial 2023: Assessment for bleeding disorder with tailored post-operative care Highlights & Side Effects. Trial Name: NCT05846854 — N/A
Assessment for bleeding disorder with tailored post-operative care 2023 Treatment Timeline for Medical Study. Trial Name: NCT05846854 — N/A
~15 spots leftby Nov 2025
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