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HEPATIC: Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children

Sponsor
University Medical Center Groningen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05818644
Collaborator
(none)
400
Enrollment
1
Location
20
Anticipated Duration (Months)
20
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to investigate the prevalence, current management practices, and outcomes in pediatric patients with HAC after liver transplantation.

Research question:

  • What are the overall prevalence of HAC and efficacy of all treatment strategies for HAC after pediatric LT?

  • What are the current management practice in the experience of centers, anticoagulant therapy, screening protocol, and assessment criteria for HAC after pediatric LT?

The burden of participation is considered to be minimal, and limited to the questionnaires.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children: a Multicenter, Retrospective, Observational Study
    Anticipated Study Start Date :
    Apr 1, 2023
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Conservative treatment
    Surgical revascularization
    Endovascular revascularization
    Re-transplantation

    Outcome Measures

    Primary Outcome Measures

    1. Graft survival [1-1-2001 and 1-1-2023]

      Graft survival is defined as a functioning graft from transplantation to the end of follow-up data, re-transplantation, or death, whichever occurs first

    2. Patient survival [1-1-2001 and 1-1-2023]

      Patient survival was defined from date of primary LT until date of death. Causes of re-transplantation or death will be recorded.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Patient is diagnosed with HAC (HAS or HAT) after LT

    • The age of the patient is below 18 years at the time of diagnosis and intervention

    • The date of diagnosis or intervention was between 1st January 2002 and 1st January

    1. HAC occurring after first or subsequent LTs are included.
    Exclusion criteria:

    N/A

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Medical Center Groningen Groningen Netherlands 9700 RB

    Sponsors and Collaborators

    • University Medical Center Groningen

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT05818644
    Other Study ID Numbers:
    • 17033
    First Posted:
    Apr 19, 2023
    Last Update Posted:
    Apr 24, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Thrombosis
    Constriction, Pathologic

    Study Results

    No Results Posted as of Apr 24, 2023