Trials Sponsors Conditions Drugs Pricing

Conditions

Acquired Von Willebrand Disease Alagille Syndrome Pulmonary Artery Stenoses

Outcome Measures

Primary Outcomes (3)

Blood product volume
Intra-operatively through 24 hours post-operatively
Chest tube output blood volume
Intra-operatively through 24 hours post-operatively
Number of participants with pulmonary hemorrhage
Intra-operatively through 24 hours post-operatively

Secondary Outcomes (1)

Incidence of thromboembolism events in patients with hematologic condition
Intra-operatively through 30 days post-operatively

Study Arms (2)

Alagille syndrome

EXPERIMENTAL

Patients with complex cardiac conditions requiring cardiothoracic surgery who also have a history of Alagille syndrome.

Other: Assessment for bleeding disorder with tailored post-operative care

No history of Alagille syndrome

EXPERIMENTAL

Patients with complex cardiac conditions requiring cardiothoracic surgery who do not have a diagnosis of Alagille syndrome.

Other: Assessment for bleeding disorder with tailored post-operative care

Interventions

Assessment for bleeding disorder with tailored post-operative careOther

Intervention will be expanded lab work-up for hematologic conditions, consultation by Hematology and tailored intra-operative and post-operative plan with aim to mitigate bleeding and hemorrhage risk, balancing thrombotic risk with this intervention.

Alagille syndromeNo history of Alagille syndrome

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

AgeUp to 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

years old
with complex cardiac condition requiring pulmonary artery reconstruction (branch pulmonary artery stenosis, MAPCAs or Tetralogy of Fallot without MAPCAs)

You may not qualify if:

Sponsors & Collaborators

Stanford University
Otherlead
Alagille Syndrome Alliance
Type not reportedcollaborator

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

MeSH Terms

Conditions

Alagille SyndromeStenosis, Pulmonary Artery

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesAbnormalities, MultipleCongenital Abnormalities

Study Officials

Noelle Ebel, MD
Stanford University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NON RANDOMIZED
Masking: NONE
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Associate Professor, Division of Pediatric Gastroenterology, Hepatology and Nutrition

Study Record Dates

First Submitted

April 26, 2023

First Posted

May 6, 2023

Study Start

April 18, 2023

Actual (reported)

Primary Completion

November 2024

Estimated (date passed)

Decreasing Hemorrhage Risk in Children With Alagille Syndrome

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (2)

Alagille syndrome

No history of Alagille syndrome

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (1)

Study Arms (2)

Alagille syndrome

No history of Alagille syndrome

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations