Brain DeathNCT01819116
Organ Donor Tissue Oxygen Saturation as a Predictor of Number of Organs to Transplant Per Donor
An observational study of Brain Death, run by The Cleveland Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Brain Death
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Mar 2014
- Phase
- Observational
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: DNC Organ Donor managed by Lifebanc
Who may be able to join
- DNC organ donor
- Age ≥ 15 years old
- Weight ≥ 45 Kg
Who cannot join
- Donor after circulatory determination of death
- Living donor
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tissue Oxygen Saturation During Management of the Deceased by Neurological Criteria Organ Donor as a Predictor of Number of Organs to Transplant Per Donor
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.
Read the detailed description
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.
- Conditions
- Brain Death
- Keywords
- Tissue Oxygen Saturation, Management of the DNC Organ Donor
- Medical subject headings
- Brain Death
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of organs transplanted per donor
Measured: At 24 hours after transfering the donor to operating room.
Secondary outcomes (4)
Number of organs with targeted end-organ function per donor
Normal end-organ function definitions
- Kidney function: Creatinine ≤ 1.5 mg/dL, urinary output ≥ 0.5 ml/kg/h
- Liver function: INR <1.5, Prothrombin time: 8.4-13 seconds (or within normal range per testing lab). Bilirubin, AST, ALT within normal range per laboratory limits.
- Lung function: PaO2/FiO2 index ≥ 300 with PEEP ≤ 8 (oxygen challenge gas)
- Heart function: Normal systolic and diastolic function per echocardiogram with minimal inotropic/vasopressor support. Systolic function will be estimated by ejection fraction and/or shortening fraction on echocardiogram. Normal cardiac catheterization data if available
- Pancreatic function: HbA1c<6, amylase and lipase within normal range per laboratory limits.
- Small intestine function: lactate ≤ 2.2 mmol/L with minimal vasopressor support.
Measured: 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
Measured: 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
Mean arterial pressure, central venous pressure, cardiac output, positive pressure variation, stroke volume variation
Measured: During donor management until cardiac arrest at the operating room
Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued.
Measured: During donor management until cardiac arrest at the operating room
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain DeathStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Perez-Protto, MD, The Cleveland Clinic
- Investigators
- Silvia Perez-Protto, MD, Principal investigator, The Cleveland ClinicDaniel Lebovitz, MD, Study director, Akron Children Hospital - LifebancJ. Steven Hata, MD, Study director, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01819116
- Sponsor's protocol ID
- 13-020
- Status last verified
- Mar 2014
- First submitted
- 19 Mar 2013
- Last updated
- 27 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Oxygen Saturation During Management of the Deceased by Neurological Criteria Organ Donor as a Predictor of Number of Organs to Transplant Per Donor
- ClinicalTrials.gov ID
- NCT01819116
- Acronym / sponsor ID
- 13-020
- Conditions
- Brain Death
- Keywords
- Tissue Oxygen Saturation, Management of the DNC Organ Donor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 27 Mar 2013 (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 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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- DNC Organ Donor managed by Lifebanc
Key inclusion criteria (3 listed)
- DNC organ donor
- Age ≥ 15 years old
- Weight ≥ 45 Kg
Key exclusion criteria (2 listed)
- Donor after circulatory determination of death
- Living donor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of organs transplanted per donor
Time frame: At 24 hours after transfering the donor to operating room.
4 secondary outcomes
Number of organs with targeted end-organ function per donor
Time frame: 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
Time frame: 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
Time frame: During donor management until cardiac arrest at the operating room
Variation of tissue oxygenation after thyroid hormone is initiated, titrated and/or discontinued.
Time frame: During donor management until cardiac arrest at the operating room
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2016.
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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.
Silvia Perez-Protto, MD principal investigator
The Cleveland Clinic
Daniel Lebovitz, MD study director
Akron Children Hospital - Lifebanc
J. Steven Hata, MD study director
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Death, run by The Cleveland Clinic 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 2 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: finished, as of the sponsor's last update on 27 Jan 2016. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of organs transplanted per donor (time frame: At 24 hours after transfering the donor to operating room.). 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 27 Jan 2016.