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Fingolimod as a Treatment of Cerebral Edema After Intracerebral Hemorrhage

2019-09-18 03:27:37 | BioPortfolio

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).

Description

This is a double-blinded, placebo-controlled pilot trial of fingolimod in patients with primary spontaneous intracerebral hemorrhage. Eligible participants will be allocated to study groups using fixed allocation randomization and a computer-based random number-generating allocation. Participants will be monitored at time of enrollment and days 1, 3 5, 7, and 14 (discharge dependent) by 2 blinded assessors (neuroscience subspecialists) and will receive standard of care for the duration of the study. After discharge from the hospital, participants will enter a follow up phase of 12 months, with clinic visits at 30±14 days, 90±14 days, 180±14 days, and 365±14 days. They will receive a standard of care MRI scan at the 30 day visit and standard of care CT of the brain at the 90 and 365 day visit and will be assessed with the pre-selected outcome assessments established by the NINDS Common Data Elements for Stroke at these time points.

Study Design

Conditions

Intracerebral Hemorrhage

Intervention

Fingolimod 0.5 mg, Placebo, Standard of care

Location

Wake Forest University Health Sciences
Winston-Salem
North Carolina
United States
27157

Status

Not yet recruiting

Source

Wake Forest University Health Sciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-18T03:27:37-0400

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Medical and Biotech [MESH] Definitions

The minimum acceptable patient care, based on statutes, court decisions, policies, or professional guidelines.

Organization of medical and nursing care according to the degree of illness and care requirements in the hospital. The elements are intensive care, intermediate care, self-care, long-term care, and organized home care.

Misunderstanding among individuals, frequently research subjects, of scientific methods such as randomization and placebo controls.

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