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Cooling to Optimize Organ Life in Donor Study (COOLDonor)

Primary Purpose

Organ Transplantation From Brain-dead Donors

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Cold isotonic fluid and central venous hypothermia catheter
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Organ Transplantation From Brain-dead Donors focused on measuring Brain-death, organ donation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pittsburgh Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Hypothermia (32-33 degree C)

Normothermia (36.5 - 37.5 degree C)

Arm Description

Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter

Normothermia will be maintained until organ procurement as per current standard of care

Outcomes

Primary Outcome Measures

Feasibility and safety
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
Data on recipient survival and allograft function will be collected up to 6 months following transplantation
Interleukin-6
Actual no. of organs transplanted
Malondialdehyde
Death receptor-5
lactate
Urinary isoprostanes

Full Information

First Posted
November 21, 2011
Last Updated
February 5, 2018
Sponsor
University of Pittsburgh
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1. Study Identification

Unique Protocol Identification Number
NCT01544530
Brief Title
Cooling to Optimize Organ Life in Donor Study
Acronym
COOLDonor
Official Title
Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding and other logistic reasons
Study Start Date
March 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Organ Transplantation From Brain-dead Donors
Keywords
Brain-death, organ donation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypothermia (32-33 degree C)
Arm Type
Experimental
Arm Description
Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter
Arm Title
Normothermia (36.5 - 37.5 degree C)
Arm Type
No Intervention
Arm Description
Normothermia will be maintained until organ procurement as per current standard of care
Intervention Type
Other
Intervention Name(s)
Cold isotonic fluid and central venous hypothermia catheter
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility and safety
Description
Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours
Time Frame
From enrollment to organ procurement (average of 24 hours)
Secondary Outcome Measure Information:
Title
Six-month hospital free survival in recipients
Description
Data on recipient survival and allograft function will be collected up to 6 months following transplantation
Time Frame
6 months
Title
Interleukin-6
Time Frame
Baseline, 6 hours, and at organ procurement (15-24 hrs)
Title
Actual no. of organs transplanted
Time Frame
At the time of organ procurement
Title
Malondialdehyde
Time Frame
Baseline, 6 hours, and at organ procurement (15-24 hrs)
Title
Death receptor-5
Time Frame
Baseline, 6 hours, and at organ procurement (15-24 hrs)
Title
lactate
Time Frame
Baseline, 6 hours, and at organ procurement (15-24 hrs)
Title
Urinary isoprostanes
Time Frame
Baseline, 6 hours, and at organ procurement (15-24 hrs)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States

12. IPD Sharing Statement

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Cooling to Optimize Organ Life in Donor Study

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