Completed

Tissue Oxygen Saturation During Management of the Deceased by Neurological Criteria Organ Donor as a Predictor of Number of Organs to Transplant Per Donor

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Brain Diseases+9

+ Central Nervous System Diseases

+ Coma

Over 15 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: April 2013
See protocol details

Summary

Principal SponsorThe Cleveland Clinic
Last updated: January 27, 2016
Sourced from a government-validated database.Claim as a partner

Study start date: April 1, 2013

Actual date on which the first participant was enrolled.

Specifically the study aims to: Evaluate the association between StO2 level in the DNC organ donor and the number of organs transplanted per donor; Evaluate whether or not tissue perfusion in the DNC organ donor population correlates with currently measured macro-hemodynamic variables during the donor management phase. Assess if StO2 in the DNC organ donor is related to the number of organs with normal end-organ function, and with the number of organs predicted to be transplanted using the organ donor calculator. Assess if StO2 in the DNC organ donor is related with intravenous thyroid hormone treatment. Investigators will conduct an observational study, including 60 DNC organ donors, in Lifebanc's Donor Service Area (DSA). Investigators will monitor and record blindly the StO2 with near-infrared spectroscopy (NIRS) in the DNC organ donor from the beginning of the OPO (Organ Procurement Organization) organ donor management period until cardiac arrest in the operating room at the time of recovery.

Principal SponsorThe Cleveland Clinic
Last updated: January 27, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Brain DiseasesCentral Nervous System DiseasesComaConsciousness DisordersDeathNervous System DiseasesNeurologic ManifestationsPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessNeurobehavioral ManifestationsBrain Death

Criteria

3 inclusion criteria required to participate
Age >= 15 years old

DNC organ donor

Weight >= 45 Kg

2 exclusion criteria prevent from participating
Donor after circulatory determination of death

Living donor

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Cleveland Clinic

Cleveland, United StatesOpen Cleveland Clinic in Google Maps
CompletedOne Study Center