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Completed

NCT Number: NCT01805895

A Pilot Study of Minocycline in Intracerebral Hemorrhage Patients

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.

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Key information

Conditions

Intracerebral Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Hemorrhage Hemorrhagic Stroke Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Vascular Diseases cyclopia sequence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Georgia Health Sciences University

Augusta, Georgia, 30912, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Minocycline

Drug

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.

Other names: Dynacin, Minocin

Primary outcomes

  1. Modified Rankin Scale

    Time frame: 90 days

    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.

Secondary outcomes

  1. Safety Assessment

    Time frame: 90 days

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

Sponsors and collaborators

Lead sponsor

Augusta University

Other

Collaborators

  • American Heart Association

Registry information

Official study title

Minocycline in Acute Cerebral Hemorrhage (MACH) Trial

Acronym: MACH

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2013
Registry last updated
Apr 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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