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Trial record 17 of 46 for:    Open Studies | "Organ Transplantation"
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Cooling to Optimize Organ Life in Donor Study (COOLDonor)

This study is currently recruiting participants.
Verified March 2012 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01544530
First received: November 21, 2011
Last updated: April 16, 2012
Last verified: March 2012
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Hypothermia
U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

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


Secondary Outcome Measures:
  • Six-month hospital free survival in recipients [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Data on recipient survival and allograft function will be collected up to 6 months following transplantation

  • Interleukin-6 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
  • Actual no. of organs transplanted [ Time Frame: At the time of organ procurement ] [ Designated as safety issue: Yes ]
  • Malondialdehyde [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
  • Death receptor-5 [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
  • lactate [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]
  • Urinary isoprostanes [ Time Frame: Baseline, 6 hours, and at organ procurement (15-24 hrs) ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01544530

Contacts
Contact: Raghavan Murugan, MD, MS, FRCP 412-647-1263 muruganr@ccm.upmc.edu

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Principal Investigator: Raghavan Murugan, MD, MS, FRCP            
Sponsors and Collaborators
University of Pittsburgh
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01544530     History of Changes
Other Study ID Numbers: CORID - 335
Study First Received: November 21, 2011
Last Updated: April 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Brain-death
organ donation

Additional relevant MeSH terms:
Brain Death
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Coma
Unconsciousness
 Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Death
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013