Cooling to Optimize Organ Life in Donor Study

Organ Transplantation From Brain-dead Donors Clinical Trial

— COOLDonor  

Official title:

Feasibility of Mild-to-moderate Therapeutic Hypothermia as an In-vivo Organ Preservation Strategy in Brain-dead Donors

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01544530
• Other study ID #: CORID - 335
• Status: Terminated
• Phase: Phase 2
• First received: November 21, 2011
• Last updated: February 5, 2018
• Start date: March 2012
• Est. completion date: March 2014

Study information

• Verified date: February 2018
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Death
• Organ Transplantation From Brain-dead Donors

Intervention

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

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility and safety	Brain-dead organ donors will be followed from study enrollment up to organ procurement for an average of 24 hours	From enrollment to organ procurement (average of 24 hours)
Secondary	Six-month hospital free survival in recipients	Data on recipient survival and allograft function will be collected up to 6 months following transplantation	6 months
Secondary	Interleukin-6		Baseline, 6 hours, and at organ procurement (15-24 hrs)
Secondary	Actual no. of organs transplanted		At the time of organ procurement
Secondary	Malondialdehyde		Baseline, 6 hours, and at organ procurement (15-24 hrs)
Secondary	Death receptor-5		Baseline, 6 hours, and at organ procurement (15-24 hrs)
Secondary	lactate		Baseline, 6 hours, and at organ procurement (15-24 hrs)
Secondary	Urinary isoprostanes		Baseline, 6 hours, and at organ procurement (15-24 hrs)