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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-operatively through 30 days post-operatively

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ intra-operatively through 30 days post-operatively

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Blood product volume

Chest tube output blood volume

Number of participants with pulmonary hemorrhage

Secondary outcome measures

Incidence of thromboembolism events in patients with hematologic condition

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,387 Previous Clinical Trials

17,334,010 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available enrollments at this moment for the clinical trial?

"The records available on clinicaltrials.gov suggest that this particular trial is not currently enrolling patients. It was initially posted on April 18th 2023, and the last update was made May 4th of the same year. Nonetheless, there are 1,806 other trials actively recruiting at present."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decreasing Hemorrhage Risk in Children With Alagille Syndrome

Noelle Hanako 2023. "Decreasing Hemorrhage Risk in Children With Alagille Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05846854.

All > Von Willebrand Disease