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Trial record 15 of 15 for:    TNFRSF10B

Cooling to Optimize Organ Life in Donor Study (COOLDonor)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01544530
Recruitment Status : Terminated (Lack of funding and other logistic reasons)
First Posted : March 6, 2012
Last Update Posted : February 7, 2018
Information provided by (Responsible Party):
Raghavan Murugan, University of Pittsburgh

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Organ Transplantation From Brain-dead Donors Other: Cold isotonic fluid and central venous hypothermia catheter Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors
Study Start Date : March 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypothermia

Arm Intervention/treatment
Experimental: Hypothermia (32-33 degree C)
Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter
Other: Cold isotonic fluid and central venous hypothermia catheter
20-30ml/kg of isotonic crystalloid resuscitation fluid will be used for induction. Hypothermia (32-33 degrees C) will be sustained until organ procurement using an FDA approved central venous catheter connected to an external temperature regulating system

No Intervention: Normothermia (36.5 - 37.5 degree C)
Normothermia will be maintained until organ procurement as per current standard of care

Primary Outcome Measures :
  1. Feasibility and safety [ Time Frame: From enrollment to organ procurement (average of 24 hours) ]
    Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours

Secondary Outcome Measures :
  1. Six-month hospital free survival in recipients [ Time Frame: 6 months ]
    Data on recipient survival and allograft function will be collected up to 6 months following transplantation

  2. Interleukin-6 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  3. Actual no. of organs transplanted [ Time Frame: At the time of organ procurement ]
  4. Malondialdehyde [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  5. Death receptor-5 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  6. lactate [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]
  7. Urinary isoprostanes [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01544530

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United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh

Additional Information:
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Responsible Party: Raghavan Murugan, Associate Professor, University of Pittsburgh Identifier: NCT01544530     History of Changes
Other Study ID Numbers: CORID - 335
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: February 7, 2018
Last Verified: February 2018
Keywords provided by Raghavan Murugan, University of Pittsburgh:
organ donation
Additional relevant MeSH terms:
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Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Pathologic Processes