Study of Stroke Related Edema Treatments

• Status: Withdrawn
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Stroke remains the fourth leading cause of death in the United States (second worldwide) and a leading cause of long-term disability, resulting in total direct and indirect costs of approximately $73.7 billion annually. The failure of novel therapies in clinical trials demonstrates that the complex neural response to stroke must be targeted at multiple levels to improve patient outcomes. Despite significant improvements in stroke treatment and management, 1 year survival rate among stroke patients aged 65 years or more is around 25%, and 5- year survival rate amounts to approximately 50%. The highest chances of death are within 30 days of stroke. Mortality increases due to worsening brain dysfunction, elevated intracranial pressure (ICP), and other comorbid conditions.

Treatments aimed at reducing post-stroke cytotoxic edema may reduce the risk for development of malignant stroke and mortality. Current treatments such as osmo-therapy and hemicraniectomy have substantial limitations, and mortality remains high, despite these measures outcomes remain unsatisfactory. There is a great need for alternative medical approaches which are safe, predictable, and help to ameliorate post stroke edema.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Treatments: Conivaptan; Mannitol

Criteria

Inclusion Criteria:

• Subjects with age ≥18 years and ≤80 years at the time of screening.

• Hemorrhagic stroke or large vessel ischemic stroke patients diagnosed by MRI or CT scan of Head.

• Subjects who have presented to hospital within 24 hours of symptom onset.

• The subject or his/ her legal representative is willing to undergo informed consent process prior to enrollment into this study.

Exclusion Criteria:

• Subject with age < 18 years and >80 years at the time of screening.

• Subjects with absence of stroke by imaging of brain by CT scan or MRI.

• Lacunar stroke or small vessel stroke.

• Time of symptom onset cannot be determined.

• Subjects with renal or hepatic failure.

• Subjects with hypovolemia or hypotension as determined by the study team.

• Subjects with hypernatremia.

• Subject who is pregnant or lactating.

• Subject is already participating in other investigational clinical trial.

• The subject or legal representative is unable to provide informed consent.

• The subject is medically unstable to participate in the trial as determined by the principal investigator.

• The subject has any end stage medical condition as determined by the principal investigator.