Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage (NCT04088630) | Clinical Trial Compass
CompletedEarly Phase 1
Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage
United States28 participantsStarted 2020-08-07
Plain-language summary
The purpose of this study is to test the safety and effectiveness of a single dose of fingolimod in patients with primary spontaneous intracerebral hemorrhage (ICH).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
Has given written informed consent to participate in the study in accordance with required regulations; if a participant is not capable of providing informed consent, written consent must be obtained from the participant's legally authorized representative (LAR). When the LAR is not available for consent, Docusign for econsent may be obtained.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Men and non-pregnant women ages 18-80 years old Has a confirmed diagnosis of spontaneous supratentorial ICH. The presence of cerebellar ICH is exclusionary. Presence of hydrocephalus due to mass effect and cerebral edema is not exclusionary. If the patient has hydrocephalus requiring CSF drainage, an external ventricular drain will be placed as standard of care and will not be exclusionary.
Symptoms less than 24 hours prior to enrollment if all eligibility criteria are met. An unknown time of onset is exclusionary. Use the time the patient was last known to be well for patients that awaken from sleep with symptoms.
Has a GCS score ≥ 5 on presentation. Has a National Institutes of Health Stroke Scale (NIHSS) score ≥ 4 on presentation.
Maintenance of SBP \< 200 mmHg at the time of enrollment and randomization. Historical Modified Rankin Scale score of 0-2.
Exclusion Criteria:
Men or women \< 18 years old Incarcerated patients ICH known as a result of trauma. Primary intraventricular hemorrhage without signific…
What they're measuring
1
Number of Participants With Clinically Significant Cardiac Events
Timeframe: up to 30 days post-ictus
2
Rate of Nosocomial Infections (UTI, Sepsis, and Pneumonia)