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Low enrollment
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| Name | Class |
|---|---|
| Laerdal Foundation | OTHER |
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Cardiac arrest is the most common cause of death in the United States and as many as 590,000 Americans suffering a cardiac arrest each year. Despite advances in care, as many as 50 to 89% of patients who are resuscitated after a cardiac arrest die in the hospital. Brain injury is the most common cause of death and disability after cardiac arrest. The investigators use advanced brain monitoring in patients who are at high risk of death after cardiac arrest, with the goal of preventing ongoing brain injury. The most common problem the investigators have observed is low oxygen levels in the brain, which is often very difficult to treat.
In this study, the investigators plan to use two additional brain monitors in the care of these high risk patients: a monitor for seizures and a monitor of the amount of blood flow in the brain. The investigators will use these to detect and treat potential causes of low brain oxygen levels. The main hypotheses are that electrical events in the brain such as seizures and "spreading depolarizations" will occur during times of low brain tissue oxygen level, and that treating these events and low blood flow will reduce the rate of low brain oxygen levels.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac arrest | Experimental | Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) | Device |
| ||
| Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) |
| Measure | Description | Time Frame |
|---|---|---|
| Spreading Depolarizations | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days | |
| Occult Seizures | Seizures detected by intracortical EEG but not surface EEG | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
| Cerebral Hypoperfusion | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically Significant Bleeding | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks | |
| Monitor-associated Infection | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cardiac Arrest | Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cardiac Arrest | Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Spreading Depolarizations | Posted | Count of Participants | Participants | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
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Duration of index hospitalization, a median of 3 days.
Patients were examined by a study investigator daily to assess for adverse events until death or discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cardiac Arrest | Survivors of cardiac arrest at high risk of neurological deterioration. Participants will undergo placement of a Spencer Probe Depth Electrode and QFlow 500™ Perfusion Probe in addition to the institutional standard multimodal neurological monitoring. QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA) Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Elmer | University of Pittsburgh | 412-647-9489 | elmerjp@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2018 | Sep 16, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D020196 | Trauma, Nervous System |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009422 | Nervous System Diseases |
| D014947 | Wounds and Injuries |
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| Device |
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| Device Malfunction | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | Occult Seizures | Seizures detected by intracortical EEG but not surface EEG | Posted | Count of Participants | Participants | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
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| Primary | Cerebral Hypoperfusion | Posted | Count of Participants | Participants | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
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| Secondary | Clinically Significant Bleeding | Posted | Count of Participants | Participants | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks |
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| Secondary | Monitor-associated Infection | Posted | Count of Participants | Participants | Participants will be followed for the duration of the initial hospitalization, an expected average of 2 weeks |
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| Secondary | Device Malfunction | Posted | Count of Participants | Participants | Participants will be followed for the duration of invasive monitoring, an expected average of 5 days |
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| 3 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |