A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Completed · Phase 1/Phase 2

Conditions studied: Intracerebral Hemorrhage

In brief

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.

Key facts

Study ID

NCT01805895

Run by

Augusta University

People needed

16

Starts

2013-02-01

Expected to finish

2016-12-01

Last updated by the study team

2018-04-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Georgia Health Sciences University — Augusta, Georgia, United States

Full record on ClinicalTrials.gov

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