A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

Augusta University16 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Intracerebral Hemorrhage

Interventions

MinocyclineDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Georgia Health Sciences University

Augusta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 90 days

Secondary Outcomes

Safety Assessment

Adverse events will be asses for 90 days. This will serve as our safety endpoint.

Time frame: 90 days

Data from ClinicalTrials.gov

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