Organ Transplantation From Brain-dead DonorsPhase 2COOLDonorNCT01544530
Cooling to Optimize Organ Life in Donor Study
A Phase 2 study testing Cold isotonic fluid and central venous hypothermia catheter in people with Organ Transplantation From Brain-dead Donors, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Organ Transplantation From Brain-dead Donors
- What is being tested?
- Cold isotonic fluid and central venous hypothermia catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Mar 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15261
About this study
Official title: Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors
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.
- Being tested
- Cold isotonic fluid and central venous hypothermia catheter
- Keywords
- Brain-death, organ donation
- Medical subject headings
- Brain Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold isotonic fluid and central venous hypothermia catheterOther
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
| Study group | Role | What they receive |
|---|---|---|
| Hypothermia (32-33 degree C) | Experimental | Following randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter Receives: Other: Cold isotonic fluid and central venous hypothermia catheter |
| Normothermia (36.5 - 37.5 degree C) | No intervention | Normothermia will be maintained until organ procurement as per current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety
Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours
Measured: From enrollment to organ procurement (average of 24 hours)
Secondary outcomes (7)
Six-month hospital free survival in recipients
Data on recipient survival and allograft function will be collected up to 6 months following transplantation
Measured: 6 months
Interleukin-6
Measured: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Actual no. of organs transplanted
Measured: At the time of organ procurement
Malondialdehyde
Measured: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Death receptor-5
Measured: Baseline, 6 hours, and at organ procurement (15-24 hrs)
lactate
Measured: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Urinary isoprostanes
Measured: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Lack of funding and other logistic reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Organ Transplantation From Brain-dead DonorsStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghavan Murugan, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01544530
- Sponsor's protocol ID
- CORID - 335
- Acronym
- COOLDonor
- Status last verified
- Feb 2018
- First submitted
- 21 Nov 2011
- Last updated
- 7 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors
- ClinicalTrials.gov ID
- NCT01544530
- Acronym / sponsor ID
- COOLDonor / CORID - 335
- Keywords
- Brain-death, organ donation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding and other logistic reasons
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypothermia (32-33 degree C) | Experimental | Other: Cold isotonic fluid and central venous hypothermia catheterFollowing randomization, hypothermia will be induced by a combination of cold isotonic fluid and sustained until organ procurement by a central venous catheter |
| Normothermia (36.5 - 37.5 degree C) | No intervention | –Normothermia will be maintained until organ procurement as per current standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold isotonic fluid and central venous hypothermia catheter20-30ml/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 | Other | Hypothermia (32-33 degree C) |
Primary outcome
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
7 secondary outcomes
Six-month hospital free survival in recipients
Time frame: 6 months
Interleukin-6
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Actual no. of organs transplanted
Time frame: At the time of organ procurement
Malondialdehyde
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Death receptor-5
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
lactate
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Urinary isoprostanes
Time frame: Baseline, 6 hours, and at organ procurement (15-24 hrs)
Results and safety
The study was stopped early (reason given: Lack of funding and other logistic reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cold isotonic fluid and central venous hypothermia catheter in people with Organ Transplantation From Brain-dead Donors, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Lack of funding and other logistic reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety (time frame: From enrollment to organ procurement (average of 24 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.