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Pancreas transplantation in highly sensitised patients via prioritised pancreas allocation programs: Graft survival analysis

Pancreas transplantation in highly sensitised patients via prioritised pancreas allocation programs: Graft survival analysis - HITS-P = Highly Immunized Transplant recipients – Pancreas

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00037930
Enrollment
54
Registered
2026-01-28
Start date
2026-02-01
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z94.8

Interventions

Group 1: Highly sensitized patients (preformed HLA antibodies, DSA or PRA = 90%) – recipients transplanted via the prioritized pancreas allocation program. Group 2: Non-sensitized patients (no or low

Sponsors

Klinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie
Lead Sponsor
Klinik für Allgemein- und Viszeralchirurgie Charité
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: •Patients who underwent pancreas transplantation between 2020 and 2025. •Participation in the Eurotransplant program for highly sensitized patients (HI listing) or assignment to the non-sensitized control group. •Availability of complete baseline clinical data (age, sex, blood group, BMI). •Documented immunological parameters (PRA level, DSA, HLA mismatch). •Availability of follow-up data for at least 90 days after transplantation.

Exclusion criteria

Exclusion criteria: •Patients with missing or incomplete baseline data (clinical or immunological parameters). •Missing follow-up data within the first 90 days after transplantation. •Retransplantations where assignment to HI or control group is not clearly possible. •Simultaneous or combined organ transplantations other than simultaneous pancreas-kidney transplantation (SPK), as SPK represents standard of care. •Patients who objected to the use of their data (if applicable).

Design outcomes

Primary

MeasureTime frame
90-day pancreas graft survival (time-to-event): Time from transplantation to graft loss, defined as return to permanent insulin therapy, graft explantation, or patient death with a non-functioning graft; censoring at last follow-up within 90 days.

Secondary

MeasureTime frame
•1-year pancreas graft survival (time-to-event analysis). •Patient survival after transplantation (90 days and 1 year). •Causes of graft loss (e.g., thrombosis, acute cellular or antibody-mediated rejection, chronic rejection, surgical complications). •Acute rejection episodes, differentiated into cellular and antibody-mediated. •Primary versus delayed graft function. •Early pancreas graft thrombosis rate (within 30 days). •Impact of immunological parameters (PRA levels, donor specific antibodies [DSA], HLA mismatch) on graft survival and rejection risk. •Impact of immunosuppressive regimen (induction and maintenance therapy) on graft outcomes.

Countries

Austria, Germany, Netherlands

Contacts

Public ContactFabian Haak

Klinik für Viszeral-, Transplantations-, Thorax- und Gefäßchirurgie

fabian.haak@medizin.uni-leipzig.de+49 341 97 19171

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026