FindTrial
Sign In

Prevention of narrowing of the biliary tree tract after liver transplantation by flushing the donor liver with a clot-dissolving agent

Arterial perfusion with t-PA in donation after cardiac death (DCD) to reduce the incidence of non-anastomotic biliary strictures after orthotopic liver transplantation - FLUSH

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-002478-30-NL
Enrollment
Unknown
Registered
2013-06-04
Start date
2013-06-05
Completion date
Unknown
Last updated
2013-06-17

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

Conditions

Biliary strictures after orthotopic liver transplantation caused by microthrombi in the donorliver during procurement

Interventions

Trade Name: Actilyse Product Name: Actilyse Product Code: B01AD02 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: tissue-plasminogen activator CAS Number: SID 50068525

Sponsors

Leiden University Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Recipient inclusion criteria - All patients who are eligible for liver transplantation Donor inclusion criteria - Donors from donation after cardiac death (DCD) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 152 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 42

Exclusion criteria

Exclusion criteria: Patients eligible for liver transplantation younger than <18 Pregnant women

Design outcomes

Primary

MeasureTime frame
Main Objective: Prevention of biliary strictures after liver transplantation;Secondary Objective: • Graft survival • Patient survival • Number of graft failures due to biliary strictures ;Primary end point(s): The incidence (number) of biliary strictures after liver transplantation;Timepoint(s) of evaluation of this end point: 1) On indication due to clinical symptoms 2) Evaluation using MRI of the biliary tree 1 year after liver transplantation—

Secondary

MeasureTime frame
Secondary end point(s): 1) Graft survival 2) Patient survival 3) Number of graft failures due to biliary strictures 4) Number of ERCPs, PTCs and surgical interventions performed to treat NAS in the first year 5) Number of hospitalizations and time of hospitalization 6) Number of admission days to the Intensive Care Unit (ICU) 7) Number of episodes of cholangitis 8) Adverse events (AE) and serious adverse events (SAE) 9) Ischemia times and relation to NAS 10)Transaminase peaks (ALAT/ASAT, bilirubin) 11)Peri-operative blood loss 12)Clotting, fibinolysis and remnants of t-PA in the recipients plasma 13)Primary non-function 14)Hepatic artery thrombosis (HAT) 15)Retransplantations due to biliary strictures 16)1-week liver biopsy for evaluation of ischemia/reperfusion damage ;Timepoint(s) of evaluation of this end point: 1) On indication (retransplantation) 2) On indication 3) On indication (clinical symptoms) within 1 year 4) On indication (clinical symptoms) within 1 year 5) On indication (clinical symptoms) within 1 year 6) On indication (clinical symptoms) within 1 year 7) On indication (clinical symptoms) within 1 year 8) On indication (clinical symptoms) within 1 year 9) pre-operatively 10) 1week post transplantation 11) per-operatively 12) per-operatively 13) On indication (clinical symptoms) within 1 year 14) On indication (clinical symptoms) within 1 year 15) On indication (clinical symptoms) within 1 year 16) 1 week post-transplantation—

Countries

Netherlands

Contacts

Public ContactFonds Nuts Ohra

Fonds Nuts Ohra

info@fondsnutsohra.nl0031205949690

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026