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Clinical Trials/ISRCTN15686690
ISRCTN15686690
Completed
Not Applicable

Controlled Oxygenated Rewarming as Adjunct in Liver transplantation (CORAL) of human allografts from extended criteria donors (ECD): a prospective randomized controlled trial

niversity Hospital Duisburg-Essen0 sites40 target enrollmentAugust 8, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preservation and implantation of liver grafts
Sponsor
niversity Hospital Duisburg-Essen
Enrollment
40
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 8, 2017
End Date
October 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospital Duisburg-Essen

Eligibility Criteria

Inclusion Criteria

  • Enhanced criteria donor according to recommendations of the German Medical Chamber:
  • 1\. Donor age \> 65 years
  • 2\. Intensive therapy including assisted ventilation \> 7 days
  • 3\. Obesity of donor (BMI \> 30\)
  • 4\. Serum Na \> 165 Mol/l
  • 5\. GOT GPT \> 3 x of normal
  • 6\. S\-Bilirubin \> 3 mg/dl
  • 7\. Liver steatosis (histologically proven) \> 40%
  • 1\. Patient suffering from end\-stage liver disease
  • 2\. Listed for liver transplantation

Exclusion Criteria

  • 1\. HU\-listed
  • 2\. Re\-transplantation
  • 3\. Simultaneous participation in other preservation trial
  • 4\. HIV\-positive
  • 5\. MELD score \>25

Outcomes

Primary Outcomes

Not specified

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