NCT02784080|Unknown
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Sponsor study identifier
observational
858
4 countries
5
Study Start
August 15, 2015
Actual (reported)Primary Completion
September 2024
Actual (reported)Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim is to evaluate the impact of donor specific HLA alloantibodies (DSA) on all-cause mortality and re-transplantation, early allograft dysfunction, acute and chronic rejection, fibrosis, vascular, and biliary complications. Furthermore, all biopsies will be C4d stained. The hypothesizes is that donor specific HLA alloantibodies facilitate an immune mediated damage to the liver allograft that impairs function and lead to various complications. The investigators will do a prospective blinded multicenter cohort study in the Scandiatransplant organ sharing organization region. Both preformed, persistent, and de novo donor specific HLA alloantibodies will studied. Blood samples will be taken immediately prior to transplantation, and 14 days, 3 months, and 1 year after transplantation. All liver biopsies performed during the study period will be evaluated for a humoral component and blood samples will be obtained prior to liver biopsies to investigate the presence of DSA. Investigations will be fully blinded for the treatment responsible doctors.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 15, 2015
Actual (reported)May 24, 2016
Actual (reported)May 26, 2016
Actual (reported)September 2024
Actual (reported)December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
All-cause mortality or re-transplantation (graft loss)
Minimum 1 year, accrual to study end
Early allograft dysfunction are defined as total bilirubin >10 mg/dl or INR >1.6 at day 7 after liver transplantation or ALT >2000 IU/L within the first 7 days after liver transplantation.
7 days after transplantation
Acute rejection, both cellular and humoral rejection, as defined by Banff classification.
Minimum 1 year, accrual to study end
Preformed, persistent, and de novo HLA-alloantibody exposure in the whole cohort.
Following analyzes will be done: LABScreen® Single Antigen, One Lambda, CA C1qScren™, One Lambda, CA (planned for later study) PE-conjugated IgG3 antibody (planned for later study) LABScreen® Mixed, One Lambda, CA (never analysed in the study)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All liver transplant recipients, both children and adults, in the Scandiatransplant region. The Scandiatransplant is an organ exchange organization that comprise of five centers in the Nordic countries: Norway, Sweden, Finland and Denmark. The five centers cover the need for liver transplantation in approximately 25 million people. From 2010-2015 the following number of transplants were done in Scandiatransplant according to the number of available donors: 323, 352, 353, 365, 388, and 401. Preliminary sample size calculations have estimated inclusion of 1062 adult and 100 pediatric patients during a study period of 3 years. Interim sample size calculations will be done, if necessary the study period will be prolonged. Pediatric patients will be analyzed separately.
Department of Surgical Gastroenterology and Transplantation, Rigshospitalet - Copenhagen University Hospital
Copenhagen, 2100, Denmark
Transplantation and Liver Surgery Clinic, Helsinki University Hospital
Helsinki, PL 372, 00029 HUS, Finland
Department of Transplantation Medicine, Oslo University Hospital
Oslo, 0424, Norway
Surgery Department, Transplantation and Liver Surgery Unit, Sahlgrenska University Hospital
Gothenburg, 413 45, Sweden
Division of Transplantation Surgery, Karolinska Institutet
Stockholm, 14186, Sweden
Kim WR, Smith JM, Skeans MA, Schladt DP, Schnitzler MA, Edwards EB, Harper AM, Wainright JL, Snyder JJ, Israni AK, Kasiske BL. OPTN/SRTR 2012 Annual Data Report: liver. Am J Transplant. 2014 Jan;14 Suppl 1:69-96. doi: 10.1111/ajt.12581.
Recipient samples, pre-transplant, at discharge or day 14 (±4 days, changed to discharge), 3 months (±3 weeks), 1 year (±1 month), and at liver biopsy * 1 Plasma, EDTA-glass (9 ml), redistributed 4 aliquots * 2 Serum, clot activator (9 ml + 4 ml), redistributed 8 aliquots * Liver biopsy sample: Formalin fixed paraffin-embeded
Allan Rasmussen, MD
Department of Surgical Gastroenterology and Transplantation, Rigshospitalet - Copenhagen University Hospital, Denmark
Andreas A Rostved, MD
Department of Surgical Gastroenterology and Transplantation, Rigshospitalet - Copenhagen University Hospital, Denmark
Helle Bruunsgaard, MD, DMSc
Department of Clinical Immunology, Centre of Diagnostic Investigation, Rigshospitalet - Copenhagen University Hospital
858 participants (actual enrollment reported by the registry).
First Submitted
May 24, 2016
First Posted
May 26, 2016
Study Start
August 15, 2015
Actual (reported)Chronic rejection, as defined by Banff classification, and as proposed by O'leary et al "Proposed Diagnostic Criteria for Chronic Antibody-Mediated Rejection in Liver Allografts".
Minimum 1 year, accrual to study end
Fibrosis, defined by METAVIR score.
Minimum 1 year, accrual to study end
Vascular complications (hepatic arterial stenosis, hepatic arterial thrombosis, portal vein thrombosis).
Minimum 1 year, accrual to study end
Contact the study team to confirm eligibility.
Primary Completion
September 2024
Actual (reported)Study Completion
December 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
September 19, 2024
Record last verified: 2024-09
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Source: ClinicalTrials.gov.
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