Hepatic Artery ThrombosisHEPATICNCT05818644
Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children
An observational study of Hepatic Artery Thrombosis and Hepatic Artery Stenosis, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 18 years
- Conditions the study is for
- Hepatic Artery Thrombosis, Hepatic Artery Stenosis, Pediatric ALL
- How many people
- 583 participants
- Where
- 1 siteNetherlands
- Study dates
- 28 Sep 2023to 23 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children: a Multicenter, Retrospective, Observational Study
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.
- Conditions
- Hepatic Artery Thrombosis, Hepatic Artery Stenosis, Pediatric ALL, Liver Transplant; Complications
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Conservative treatment | Not described | |
| Surgical revascularization | Not described | |
| Endovascular revascularization | Not described | |
| Re-transplantation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1-1-2001 and 1-1-2023
Secondary outcomes (8)
Technical success
Technical success is defined as the success of the intervention in re-establishing the arterial blood flow to the liver and will be assessed by each individual center.
Measured: 1-1-2001 and 1-1-2023
Primary and secondary patency
Primary patency is defined as the time between the index treatment and re-intervention intended to restore patency in patients with a restenosis or re-occlusion. Secondary patency is the time between the index treatment and failure to re-establish flow by means of re-intervention. In case of re-transplantation or death due to other reasons, the patients will be censored if the treated vessel is patent. Kaplan-Meier curves will be plotted to visualize primary and secondary patency rates at various times after treatment for HAC, including 1, 3, 5, 10, 15 and 20 years.
Measured: 1-1-2001 and 1-1-2023
Intra- and post-procedural complications
Procedural complications will be categorized into two main groups: transplant complications and procedural complications related to endovascular or surgical revascularization for HAC. Within these groups, intra-procedural complications predominantly consist of vascular issues, such as thrombosis, stenosis, compression, dissection, and rupture. In contrast, post-procedural complications encompass a broader range of issues, such as infection, rejection, bleeding, and vascular and biliary complications, including anastomotic stricture, non-anastomotic strictures, bile leak, biloma, or cholangitis. Re-interventions addressing both intra- and post-procedural complications will also be recorded.
Measured: 1-1-2001 and 1-1-2023
Anticoagulant therapy after transplantation and after interventions
Anticoagulant therapy after transplantation and after interventions for HAC will be assessed according to the management practices of each participating site (center specific) and individual patient data (patient specific). Details about each anticoagulation regimen, including the specific anticoagulant, duration of anticoagulation, and upper and lower limits of target values, such as international normalized ratio, anti-factor Xa, and activated partial thromboplastin time, will be recorded. Patient-specific management will be documented for patients with HAC.
Measured: 1-1-2001 and 1-1-2023
Center specific screening protocol
Local screening protocols to assess HAC after LT, such as the routine post-operative Doppler ultrasound policy, will be documented. Whether HAC screening is consistent for patients with and without risk factors will also be examined. The frequency of preferred radiological screening investigations within 2 weeks after LT will be determined, considering various risk factors.
Measured: 1-1-2001 and 1-1-2023
Center specific diagnostic criteria
The diagnostic criteria section will cover the types of HAC, non-invasive radiological criteria, and interventional radiological criteria during invasive angiography. The center's definition of technical success after interventional radiological treatment will also be recorded.
Measured: 1-1-2001 and 1-1-2023
Center specific radiological follow up
The radiological follow-up section will assess whether follow-up protocols are the same for all interventions or specific to each intervention type. The imaging methods and frequencies of radiological follow-up for different treatment modalities will be determined. Additionally, the experience years and level of seniority of the interventional radiologist will be recorded.
Measured: 1-1-2001 and 1-1-2023
Incidence
The incidence of HAC will be determined by dividing the total number of patients diagnosed with HAC between 1st of January 2002 and 1st of January 2023, who had undergone LT between 1st of January 2002 and 1st of January 2022, by the total number of patients who underwent LT at pediatric age between 1st of January 2002 and 1st of January 2022. The study will present the overall incidence of HAC during the 20-year period of 2002 to 2022, as well as the incidence during specific 5-year intervals, namely 2002 to 2007, 2007 to 2012, 2012 to 2017, and 2017 to 2022, for each complication.
Measured: 1-1-2001 and 1-1-2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start28 Sep 2023
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatic Artery ThrombosisStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 583 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- J. P. Garrahan Hospital, Hospital Italiano de Buenos Aires, Royal Children's Hospital, Medical University Innsbruck, Hospital Sirio-Libanes, Hospital Santo Antonio, Faculty of Medicine & Dentistry, University of Alberta, First Affiliated Hospital of Zhejiang University, Thomayer University Hospital, Hôpital Bicêtre, University Children's Hospital, Hannover Medical School, Universitätsklinikum Hamburg-Eppendorf, Dr Rela Institute and Medical Centre, Amrita Institute of Medical Sciences & Research Center, Max Super Speciality Hospital, Aster CMI Hospital, Papa Giovanni XXIII Hospital, Bambino Gesù Children's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Auckland City Hospital, Children's Memorial Health Institute, King Faisal Specialist Hospital & Research Center, National University Hospital, Singapore, Wits Donald Gordon Medical Centre, La Paz University Hospital, Vall d'Hebron Barcelona Hospital Campus, Karolinska Institutet, University Hospital, Geneva, Birmingham Women's and Children's Hospital, Primary Children's Hospital, Children's Hospital of Philadelphia, Children's Hospital Pittsburgh, Recanati-Miller Transplantation Institute, Mount Sinai Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, RenJi Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818644
- Sponsor's protocol ID
- 17033
- Acronym
- HEPATIC
- Status last verified
- Jun 2026
- First submitted
- 5 Apr 2023
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li W, Hartog H, Minetto J, Dip M, Gonzales E, Guerin F, Andres AM, Hernandez-Oliveros F, Jaramillo C, Melen A, Junge N, Baumann U, DiNorcia J, Florman S, Seda-Neto J, da Fonseca EA, Mazariegos G, Yemini R, de Santibanes M, Uno JW, Lin T, Liu Y, Gonsorcikova L, Bohus S, Gupte GL, McGuirk SP, Aldrian D, Seisenbacher J, Wildhaber BE, Calinescu AM, Kumar M, Gupta S, Liang T, Zhang W, Marra P, D'Antiga L, Beretta M, van der Schyff F, Ferreira CT, Farina MA, Quintero J, Mercadal-Hally M, Hardikar W, Goh L, Broering DC, Raptis DA, Shah AA, Domenick B, Pawaria A, Spada M, Alterio T, Casswall T, Jorns C, Rajakannu M, Rela M, Superina R, Caicedo JC, Dajani KZ, Parente A, Mali V, Aw MM, Asthana S, Ganjoo N, Yanagi Y, Uchida H, Ugwu GC, Lunter GA, Bokkers RPH, van der Doef HPJ; HEPATIC study group. Outcomes of hepatic artery thrombosis after paediatric liver transplantation (HEPATIC): an international, multicentre, retrospective registry study. Lancet Child Adolesc Health. 2026 Oct 14:S2352-4642(26)00218-X. doi: 10.1016/S2352-4642(26)00218-X. Online ahead of print.
PubMed 42874625Li 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.
PubMed 38866577
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hepatic Artery Stenosis and Thrombosis After Liver Transplantation in Children: a Multicenter, Retrospective, Observational Study
- ClinicalTrials.gov ID
- NCT05818644
- Acronym / sponsor ID
- HEPATIC / 17033
- Conditions
- Hepatic Artery Thrombosis, Hepatic Artery Stenosis, Pediatric ALL, Liver Transplant; Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 583 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- J. P. Garrahan Hospital, Hospital Italiano de Buenos Aires, Royal Children's Hospital, Medical University Innsbruck, Hospital Sirio-Libanes, Hospital Santo Antonio, Faculty of Medicine & Dentistry, University of Alberta, First Affiliated Hospital of Zhejiang University, Thomayer University Hospital, Hôpital Bicêtre, University Children's Hospital, Hannover Medical School, Universitätsklinikum Hamburg-Eppendorf, Dr Rela Institute and Medical Centre, Amrita Institute of Medical Sciences & Research Center, Max Super Speciality Hospital, Aster CMI Hospital, Papa Giovanni XXIII Hospital, Bambino Gesù Children's Hospital, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Auckland City Hospital, Children's Memorial Health Institute, King Faisal Specialist Hospital & Research Center, National University Hospital, Singapore, Wits Donald Gordon Medical Centre, La Paz University Hospital, Vall d'Hebron Barcelona Hospital Campus, Karolinska Institutet, University Hospital, Geneva, Birmingham Women's and Children's Hospital, Primary Children's Hospital, Children's Hospital of Philadelphia, Children's Hospital Pittsburgh, Recanati-Miller Transplantation Institute, Mount Sinai Hospital, Ann & Robert H Lurie Children's Hospital of Chicago, RenJi Hospital
- Study start
- 28 Sep 2023 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Conservative treatment | – | – |
| Surgical revascularization | – | – |
| Endovascular revascularization | – | – |
| Re-transplantation | – | – |
Who may qualify
- Ages
- 0 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Graft survival
Time frame: 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.
Patient survival
Time frame: 1-1-2001 and 1-1-2023
Patient survival is defined from the date of the primary LT until date of death. Causes of re-transplantation or death will be recorded.
8 secondary outcomes
Technical success
Time frame: 1-1-2001 and 1-1-2023
Primary and secondary patency
Time frame: 1-1-2001 and 1-1-2023
Intra- and post-procedural complications
Time frame: 1-1-2001 and 1-1-2023
Anticoagulant therapy after transplantation and after interventions
Time frame: 1-1-2001 and 1-1-2023
Center specific screening protocol
Time frame: 1-1-2001 and 1-1-2023
Center specific diagnostic criteria
Time frame: 1-1-2001 and 1-1-2023
Center specific radiological follow up
Time frame: 1-1-2001 and 1-1-2023
Incidence
Time frame: 1-1-2001 and 1-1-2023
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Derived from this study: PubMed 42874625Li W, Hartog H, Minetto J, Dip M, Gonzales E, Guerin F, Andres AM, Hernandez-Oliveros F, Jaramillo C, Melen A, Junge N, Baumann U, DiNorcia J, Florman S, Seda-Neto J, da Fonseca EA, Mazariegos G, Yemini R, de Santibanes M, Uno JW, Lin T, Liu Y, Gonsorcikova L, Bohus S, Gupte GL, McGuirk SP, Aldrian D, Seisenbacher J, Wildhaber BE, Calinescu AM, Kumar M, Gupta S, Liang T, Zhang W, Marra P, D'Antiga L, Beretta M, van der Schyff F, Ferreira CT, Farina MA, Quintero J, Mercadal-Hally M, Hardikar W, Goh L, Broering DC, Raptis DA, Shah AA, Domenick B, Pawaria A, Spada M, Alterio T, Casswall T, Jorns C, Rajakannu M, Rela M, Superina R, Caicedo JC, Dajani KZ, Parente A, Mali V, Aw MM, Asthana S, Ganjoo N, Yanagi Y, Uchida H, Ugwu GC, Lunter GA, Bokkers RPH, van der Doef HPJ; HEPATIC study group. Outcomes of hepatic artery thrombosis after paediatric liver transplantation (HEPATIC): an international, multicentre, retrospective registry study. Lancet Child Adolesc Health. 2026 Oct 14:S2352-4642(26)00218-X. doi: 10.1016/S2352-4642(26)00218-X. Online ahead of print.
- Derived from this study: PubMed 38866577Li 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatic Artery Thrombosis and Hepatic Artery Stenosis, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graft survival (time frame: 1-1-2001 and 1-1-2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05818644, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.