NCT01819116

Brief Summary

The objective of this study is to quantify the association between tissue oxygen saturation (StO2) during the donor management phase of the Death by Neurological Criteria (DNC) organ donor and the number of organs transplanted per donor.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 19, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 27, 2013

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

January 27, 2016

Status Verified

March 1, 2014

Enrollment Period

11 months

First QC Date

March 19, 2013

Last Update Submit

January 26, 2016

Conditions

Brain Death

Keywords

Tissue Oxygen SaturationManagement of the DNC Organ Donor

Outcome Measures

Primary Outcomes (1)

  • Number of organs transplanted per donor

    At 24 hours after transfering the donor to operating room.

Secondary Outcomes (4)

  • Number of organs with targeted end-organ function per donor

    At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.

  • Number of organs predicted to be transplanted using organ donor calculator

    At the last hour at the Intensive Care Unit, before the donor is transferred to the operating room.

  • Correlation of tissue oxygenation readings to macro-hemodynamic measurements

    During donor management until cardiac arrest at the operating room

  • Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued.

    During donor management until cardiac arrest at the operating room

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

DNC Organ Donor managed by Lifebanc

You may qualify if:

  • DNC organ donor
  • Age ≥ 15 years old
  • Weight ≥ 45 Kg

You may not qualify if:

  • Donor after circulatory determination of death
  • Living donor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Brain Death

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesComaUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Silvia Perez-Protto, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • Daniel Lebovitz, MD

    Akron Children Hospital - Lifebanc

    STUDY DIRECTOR

  • J. Steven Hata, MD

    The Cleveland Clinic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 27, 2013

Study Start

April 1, 2013

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

January 27, 2016

Record last verified: 2014-03

Locations

US(1)