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Clinical Trials/NL-OMON47263
NL-OMON47263
Completed
Phase 3

A Multicenter Randomized Controlled Trial to Compare the Efficacy of End-ischemic Dual Hypothermic Oxygenated Perfusion with Standard Static Cold Storage of Liver Grafts Donated after Circulatory Death in Preventing Non-anastomotic Biliary Strictures after Transplantation - DHOPE-DCD Trial

niversitair Medisch Centrum Groningen0 sites120 target enrollmentTBD
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ConditionsEnd-stage liver disease100179431001965410019818

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
End-stage liver disease
Sponsor
niversitair Medisch Centrum Groningen
Enrollment
120
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

Trial is onging in other countries

Registry
who.int
Start Date
TBD
End Date
January 11, 2020
Last Updated
2 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •\- Adult patients (\>\= 18 years old) with end\-stage liver disease
  • •\- Signed informed consent
  • •\- Willing and able to attend follow\-up examinations
  • •\- Donor liver graft from a controlled donation after circulatory death (Maastricht category III)
  • •\- Donors with a body weight \>\=40 kg

Exclusion Criteria

  • •\- Simultaneous participation in another clinical trial that might possibly influence this trial
  • •\- Mental conditions rendering the subject incapable to understand the nature, scope and consequences of the trial
  • •\- Listed for liver transplantation due to fulminant liver failure or retransplantation because of PNF
  • •\- Recipient positive test for HIV
  • •\- Donor positive for HIV, Hepatitis B or C
  • •\- Patients with contra\-indications for MRCP (i.e. pacemaker)
  • •\- Patients with simultaneous transplantation of another organ

Outcomes

Primary Outcomes

Not specified

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