Cooling to Optimize Organ Life in Donor Study

Stopped early · Phase 2

Conditions studied: Organ Transplantation From Brain-dead Donors

In brief

The purpose of this study is to assess the feasibility and safety of mild-to-moderate hypothermia as an in-vivo organ preservation strategy compared to normothermia in 60 brain-dead organ donors.

Key facts

Study ID

NCT01544530

Run by

University of Pittsburgh

People needed

4

Starts

2012-03-01

Expected to finish

2014-03-01

Last updated by the study team

2018-02-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age greater than 18 years;pronounced dead as per hospital brain-death criteria
• Accepted by organ procurement organization for organ donation
• Subjects within 3 hours of brain death pronouncement

You may not qualify if…

• Consent cannot be obtained from authorized representative;mean arterial pressure < 60 mmHg and/ or more than 2 vasopressor and/or inotrope use
• Presence of 2nd or 3rd degree heart block
• Ongoing extracranial hemorrhage
• International normalized ratio > 3.0
• Donors with human-immunodeficiency virus infection
• Pregnancy

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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