A Combined Microdialysis and FDG-PET Study for Detection of Brain Injury After Cardiac Arrest
COMA-PROTECT
1 other identifier
observational
10
1 country
1
Brief Summary
Brain injury remains the leading cause of death in comatose patients resuscitated from OHCA. One of the most challenging aspects in the treatment of a post-cardiac arrest patient is the assessment of the extent of brain damage. Reliable, clinical measures of ongoing brain injury have potential to guide individualized treatment and potentially improve outcomes. Persistent candidate measures to fill this role is combined cerebral metabolism monitoring assessed by jugular bulb microdialysis (JBM) and positron emission tomography (PET) of 18-Fluor deoxyglucose (\[F-18\]-FDG). This multimodal neuromonitoring is cutting-edge technology used in a clinical setting
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 23, 2021
CompletedStudy Start
First participant enrolled
February 25, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedApril 20, 2022
April 1, 2022
2 years
February 23, 2021
April 19, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Overall CMRglc
Cerebral metabolic rate of glucose (CMRglc)
Day 0 after cardiac arrest
Overall CMRglc
Cerebral metabolic rate of glucose (CMRglc)
Day 3 after cardiac arrest
Secondary Outcomes (2)
Jugular bulb microdialysis (JBM) LP ratio
Day 0 after cardiac arrest
JBM LP ratio
Day 3 after cardiac arrest
Eligibility Criteria
Comatose patients after OHCA admitted to the hospital with sustained return of spontaneous circulation
You may qualify if:
- Out-of-hospital cardiac arrest (OHCA) of presumed cardiac cause
- Sustained return of spontaneous circulation (ROSC), defined as ROSC when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist
- Unconsciousness (Glasgow Coma Scale (GCS) score of less than 8) after sustained ROSC
- Target temperature management (TTM) is indicated.
You may not qualify if:
- Conscious patient (GCS score of at least 8)
- In-hospital cardiac arrest (IHCA)
- OHCA of presumed non-cardiac cause, such as after trauma, dissection/rupture of major artery or arrest caused by hypoxia (i.e., drowning, hanging, etc.)
- Known bleeding diathesis (medically induced coagulopathy does not exclude patient)
- Suspected or confirmed acute intracranial bleeding
- Suspected or confirmed acute ischemic stroke
- Unwitnessed asystole
- Known limitations in therapy and do-not-resuscitate order
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Odense University Hospital
Odense, Fyn, 5000, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simon Mølstrøm, MD
Odense University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant physician
Study Record Dates
First Submitted
February 23, 2021
First Posted
February 26, 2021
Study Start
February 25, 2021
Primary Completion
March 1, 2023
Study Completion
December 1, 2023
Last Updated
April 20, 2022
Record last verified: 2022-04