A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage (NCT03038087) | Clinical Trial Compass
CompletedNot Applicable
A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage
United States10 participantsStarted 2017-02-23
Plain-language summary
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.
Who can participate
Age range22 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Male or female patients age 22 years and older
✓. Diagnostic head CT scan within 24 hours of primary spontaneous ICH symptom onset
✓. ICH \>3mL and \<90mL, as measured by the ABC method
✓. Signed written informed consent by study subject or, if subject is unable, by subject's next of kin or legal guardian
✓. Willingness and ability to comply with schedule for study procedures
Exclusion criteria
✕. Female patients who are pregnant or lactating
✕. Patients with any history of seizure or seizure at stroke onset
✕. 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
✕. Any intraventricular hemorrhage on the diagnostic (pre-enrollment) CT with planned placement of an intraventricular catheter
✕. Secondary cause of ICH suspected (e.g., arteriovenous malformation, cavernoma, aneurysm, hemorrhagic transformation ischemic stroke, venous sinus thrombosis, trauma)
✕. Planned withdrawal of care within 24 hours of enrollment
✕. Planned surgical evacuation within 24 hours of enrollment
What they're measuring
1
Number of Patients With Serious Device-related Adverse Events
Timeframe: Up to 6 Weeks
2
Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours.