Clinical trial NCT05818644: Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
Official title: Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children: a Multicenter, Retrospective, Observational Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hepatic Artery Thrombosis
Hepatic Artery Stenosis
Pediatric ALL
Liver Transplant; Complications
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: J. P. Garrahan Hospital
name: Hospital Italiano de Buenos Aires
name: Royal Children's Hospital
name: Medical University of Innsbruck
name: Hospital Sírio-Libanês
name: Hospital Santo Antonio
name: Faculty of Medicine & Dentistry, University of Alberta
name: Zhejiang University
name: Thomayer University Hospital
name: Hôpital Bicêtre
name: University Children's Hospital
name: Hannover Medical School
name: Universitätsklinikum Hamburg-Eppendorf
name: Dr Rela Institute and Medical Centre
name: Amrita Institute of Medical Sciences & Research Centre
name: Max Super Speciality Hospital
name: Aster CMI Hospital
name: ASST Papa Giovanni XXIII Hospital
name: Bambino Gesù Children's Hospital
name: National Centre for Child Health and Development
name: Auckland City Hospital
name: Children's Memorial Health Institute
name: King Faisal Specialist Hospital & Research Center
name: National University Hospital, Singapore
name: Wits Donald Gordon Medical Centre
name: La Paz University Hospital
name: Vall d'Hebron Barcelona Hospital Campus
name: Karolinska Institutet
name: University Hospital, Geneva
name: Birmingham Women's and Children's Hospital
name: Primary Children's Hospital
name: Children's Hospital of Philadelphia
name: Children's Hospital Pittsburgh
name: Recanati-Miller Transplantation Institute, Mount Sinai Hospital
name: Ann and Robert H. Lurie Children's Hospital of Chicago
First posted: 2023-04-19
Enrollment: 400
Sex: ALL
Minimum age (years): 0
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any pediatric patient diagnosed with HAC and treated for HAC (at age \<18 years) after pediatric liver transplantation between 1-1-2002 and 1-1-2023

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

Research question:

* What are the overall incidence of HAC and the effectiveness of all treatment strategies for HAC after pediatric LT?
* What are the current management practices 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.


Eligibility criteria: Inclusion criteria:

* Liver transplantation between January 1st 2002 and January 1st 2022, diagnoses of HAC after LT
* The age of the patient is below 18 years at the time of diagnosis and intervention
* The date of diagnosis of HAC or intervention was before January 1st 2023. HAC occurring after first or subsequent LTs are included.

Exclusion criteria:

N/A

Primary outcomes:
measure: Graft survival
timeFrame: 1-1-2001 and 1-1-2023
measure: Patient survival
timeFrame: 1-1-2001 and 1-1-2023
Secondary outcomes:
measure: Technical success
timeFrame: 1-1-2001 and 1-1-2023
measure: Primary and secondary patency
timeFrame: 1-1-2001 and 1-1-2023
measure: Intra- and post-procedural complications
timeFrame: 1-1-2001 and 1-1-2023
measure: Anticoagulant therapy after transplantation and after interventions
timeFrame: 1-1-2001 and 1-1-2023
measure: Center specific screening protocol
timeFrame: 1-1-2001 and 1-1-2023
measure: Center specific diagnostic criteria
timeFrame: 1-1-2001 and 1-1-2023
measure: Center specific radiological follow up
timeFrame: 1-1-2001 and 1-1-2023
measure: Incidence
timeFrame: 1-1-2001 and 1-1-2023
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: