N/A
N=10
A Study to Test the SENSE Device in Patients With Intracranial Hemorrhage
Intracerebral Hemorrhage · Stroke, Acute · Stroke Hemorrhagic
Bottom Line
View on ClinicalTrials.gov: NCT03038087 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Number of Patients With Serious Device-related Adverse Events — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SENSE Device (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Sense Diagnostics, LLC
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With Serious Device-related Adverse Events |
— | — |
| PRIMARY Number of Patients Correctly Identified by SENSE With Hemorrhage Expansion (HE) or no Hemorrhage Expansion (NHE) Within 12 Hours. |
2; 7 | — |
| SECONDARY Feasibility of the SENSE Device in a Clinical Environment |
9 | — |
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.
Eligibility Criteria
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
- Current participation in a medical or surgical interventional clinical trial
- Presence of subdural, epidural or aneurysmal subarachnoid hemorrhage on diagnostic scan
- 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
- Planned continued use of medications that, in the investigator's best clinical judgment, could increase the chances for subsequent uncontrolled hemorrhage
- Planned or current use of continuous EEG monitoring
Data sourced from ClinicalTrials.gov (NCT03038087). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.