A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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MACH is a randomized trial of minocycline in intracerebral hemorrhage. 24 total subjects will be randomly assigned to minocycline or control (1:1). The first dose will be given intravenously. Subsequent doses will be given orally every 24 hours for a total of five doses. The study will test to see if the medication is safe in intracerebral hemorrhage. The pharmacokinetics of minocycline in intracerebral hemorrhage will be determined and the impact of minocycline on blood biomarkers.

Official Title
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Minocycline in Acute Cerebral Hemorrhage (MACH) Trial

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: Minocycline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline<br>This intervention arm will receive a total of 5 doses of Minocycline. Dose 1 of Minocycline will be 400mg IV within 12-hours of onset of symptoms. Dose 2 of Minocycline will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart. | Drug: Minocycline<br>* This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.<br>* Other names: Dynacin, Minocin;|
| No Intervention: Control<br>This arm will not receive any minocycline. This arm will receive standard of care treatment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Rankin Scale | A blinded assessor will perform the modified Rankin Scale (this is the full scale name) after 90 days. This will serve as our efficacy endpoint. The scale measures function. It ranges from 0 to 6 with zero reflecting no disability, 1 to 5 increasing degrees of disability and 6 death. Lower numbers reflect preferred outcome. There are no sub scales. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessment | Adverse events will be asses for 90 days. This will serve as our safety endpoint. | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stroke, Acute Intracerebral Hemorrhage, Intracerebral Hemorrhage, Hemorrhagic stroke, Hemorrhage, Minocycline