A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

• Status: Completed
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The MACH Trial is a pilot study of 400mg minocycline over five days in acute intracerebral hemorrhage patients. The study will evaluation the safety and efficacy of minocycline in intracerebral hemorrhage patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Augusta University
• Collaborator: American Heart Association
• Treatments: Minocycline

Criteria

Inclusion Criteria:

• 18 years of age or older.

• Intracerebral hemorrhage documented by CT scan

• The first dose of the drug can be administered within 12 hours of time last known to be at baseline

Exclusion Criteria:

• Allergy to tetracycline antibiotics

• Pregnancy or suspected pregnancy (pregnancy test will be done on women of child-bearing potential)

• Hepatic and/or renal insufficiency (LFT's >3x upper limit of normal; Creatinine >2mg/dL)

• History of intolerance to minocycline

• National Institutes of Health Stroke Scale score of 4 or less

• Glasgow Coma Scale score of 5 or less

• Surgical evacuation of hematoma planned within 24 hours

• Secondary intracerebral hemorrhage resulting from trauma, arteriovenous malformation, aneurysm, tumor or other causes

• Thrombocytopenia (platelet count <75,000/mm3) or coagulopathy (INR >1.4)

• Previously not independent (prestroke modified Rankin scale score >2)

• Suspected of not being able to comply with the study protocol

• Unlikely to be available for 90 day follow-up

• Pre-existing Do Not Resuscitate (DNR) order or indication that a new DNR order will be implemented within the first 48 hours of hospitalization