NCT05818644

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 19, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

September 28, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 30, 2025

Status Verified

February 1, 2025

Enrollment Period

2.2 years

First QC Date

April 5, 2023

Last Update Submit

March 25, 2025

Conditions

Hepatic Artery ThrombosisHepatic Artery StenosisPediatric ALLLiver Transplant; Complications

Outcome Measures

Primary Outcomes (2)

  • Graft survival

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

    1-1-2001 and 1-1-2023

  • Patient survival

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

    1-1-2001 and 1-1-2023

Secondary Outcomes (8)

  • Technical success

    1-1-2001 and 1-1-2023

  • Primary and secondary patency

    1-1-2001 and 1-1-2023

  • Intra- and post-procedural complications

    1-1-2001 and 1-1-2023

  • Anticoagulant therapy after transplantation and after interventions

    1-1-2001 and 1-1-2023

  • Center specific screening protocol

    1-1-2001 and 1-1-2023

  • +3 more secondary outcomes

Study Arms (4)

Conservative treatment

Surgical revascularization

Endovascular revascularization

Re-transplantation

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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

You may qualify if:

  • 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.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Related Publications (1)

  • Li W, van der Doef HPJ, Wildhaber BE, Marra P, Bravi M, Pinelli D, Minetto J, Dip M, Sierre S, de Santibanes M, Ardiles V, Uno JW, Hardikar W, Bates S, Goh L, Aldrian D, Seisenbacher J, Vogel GF, Neto JS, Antunes da Fonseca E, Magalhaes Costa C, Ferreira CT, Nader LS, Farina MA, Dajani KZ, Parente A, Bigam DL, Liang TB, Bai X, Zhang W, Gonsorcikova L, Fronek J, Bohus S, Franchi-Abella S, Gonzales E, Guerin F, Junge N, Baumann U, Richter N, Hartleif S, Sturm E, Rajakannu M, Palaniappan K, Rela M, Pawaria A, Rajakrishnan H, Surendran S, Kumar M, Agarwal S, Gupta S, Asthana S, Bandewar V, Raichurkar K, Spada M, Monti L, Alterio T, Yanagi Y, Uchida H, Komine R, Evans H, Carr-Boyd P, Duncan D, Stefanowicz M, Latka-Grot J, Kolesnik A, Broering DC, Raptis DA, Ann H Marquez K, Mali V, Aw M, Beretta M, Van der Schyff F, Quintero-Bernabeu J, Mercadal-Hally M, Larrarte K M, Andres AM, Hernandez-Oliveros F, Frauca E, Casswall T, Jorns C, Delle M, Gupte G, Sharif K, McGuirk S, Superina R, Caicedo JC, Jaramillo C, Bitterfeld L, Kastenberg Z, Shah AA, Domenick B, Acord MR, Mazariegos GV, Soltys K, DiNorcia J, Antala S, Florman SS, Buchholz BM, Herden U, Fischer L, Dierckx RAJO, Hartog H, Bokkers RPH. Incidence, management and outcomes in hepatic artery complications after paediatric liver transplantation: protocol of the retrospective, international, multicentre HEPATIC Registry. BMJ Open. 2024 Jun 12;14(6):e081933. doi: 10.1136/bmjopen-2023-081933.

    PMID: 38866577DERIVED

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 19, 2023

Study Start

September 28, 2023

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

March 30, 2025

Record last verified: 2025-02

Locations

NL(1)