A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage
Status: | Completed |
---|---|
Conditions: | Neurology, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 1/27/2018 |
Start Date: | February 23, 2017 |
End Date: | December 31, 2017 |
An Early Feasibility Study to Evaluate the User Interfaces and Sensitivity of the SENSE Device in Patients With Intracranial Hemorrhage
The purpose of this research study is to find out whether a device for monitoring bleeding in
patients with acute hemorrhagic stroke will show similar findings as CT scans performed to
evaluate the stroke.
patients with acute hemorrhagic stroke will show similar findings as CT scans performed to
evaluate the stroke.
Inclusion Criteria:
1. Male or female patients age 22 years and older
2. Diagnostic head CT scan within 24 hours of primary spontaneous ICH symptom onset
3. ICH >3mL and <90mL, as measured by the ABC method
4. Signed written informed consent by study subject or, if subject is unable, by
subject's next of kin or legal guardian
5. Willingness and ability to comply with schedule for study procedures
Exclusion Criteria:
1. Female patients who are pregnant or lactating
2. Patients with any history of seizure or seizure at stroke onset
3. Presence or history of any other condition or finding that, in the investigator's
opinion, makes the patient unsuitable as a candidate for the SENSE device monitoring
or study participation or may confound the outcome of the study
4. Any intraventricular hemorrhage on the diagnostic (pre-enrollment) CT with planned
placement of an intraventricular catheter
5. Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma,
aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
6. Planned withdrawal of care within 24 hours of enrollment
7. Planned surgical evacuation within 24 hours of enrollment
8. Current participation in a medical or surgical interventional clinical trial
9. Presence of subdural, epidural or aneurysmal subarachnoid hemorrhage on diagnostic
scan
10. Planned continued use or prescribed use during the study of medications that, in the
investigator's best clinical judgment, are known or suspected to lower the seizure
threshold
11. Planned continued use of medications that, in the investigator's best clinical
judgment, could increase the chances for subsequent uncontrolled hemorrhage
12. Planned or current use of continuous EEG monitoring
We found this trial at
1
site
234 Goodman Dr
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: William Knight, M.D.
Phone: 513-558-8123
University of Cincinnati Medical Center Opening in 1823 as the country
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