A Combined Microdialysis and FDG-PET Study for Detection of Brain Injury After Cardiac Arrest (COMA-PROTECT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04774055 |
Recruitment Status :
Recruiting
First Posted : February 26, 2021
Last Update Posted : February 26, 2021
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Condition or disease |
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Cardiac Arrest Brain Injuries |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 10 participants |
Observational Model: | Other |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Months |
Official Title: | A Combined Microdialysis and FDG-PET Study for Detection of Brain Injury in Comatose Survivors Resuscitated From Out-of-hospital Cardiac Arrest - a Pilot Study |
Actual Study Start Date : | February 25, 2021 |
Estimated Primary Completion Date : | March 1, 2022 |
Estimated Study Completion Date : | December 1, 2022 |

- Overall CMRglc [ Time Frame: Day 0 after cardiac arrest ]Cerebral metabolic rate of glucose (CMRglc)
- Overall CMRglc [ Time Frame: Day 3 after cardiac arrest ]Cerebral metabolic rate of glucose (CMRglc)
- Jugular bulb microdialysis (JBM) LP ratio [ Time Frame: Day 0 after cardiac arrest ]Correlation between time-averaged (24 h) JBM lactate/pyruvate (LP) ratio and the overall CMRglc
- JBM LP ratio [ Time Frame: Day 3 after cardiac arrest ]Correlation between time-averaged (24 h) JBM LP ratio and the overall CMRglc

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Conscious patient (GCS score of at least 8)
- Female of child-bearing potential, unless a negative human chorionic gonadotropin (hCG) test can rule out pregnancy within the inclusion window
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04774055
Contact: Simon Mølstrøm, MD | +4561384008 | simon.molstrom@rsyd.dk | |
Contact: Palle Toft, Prof | palle.toft@rsyd.dk |
Denmark | |
Odense University Hospital | Recruiting |
Odense, Fyn, Denmark, 5000 | |
Contact: Simon Molstrom, MD 0045-61384008 smolstrom@gmail.com |
Principal Investigator: | Simon Mølstrøm, MD | Odense University Hospital |
Responsible Party: | Simon Mölström, Consultant physician, Odense University Hospital |
ClinicalTrials.gov Identifier: | NCT04774055 |
Other Study ID Numbers: |
S-20150173 HLO |
First Posted: | February 26, 2021 Key Record Dates |
Last Update Posted: | February 26, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Brain Injuries Heart Arrest Wounds and Injuries Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Heart Diseases Cardiovascular Diseases |