Minocycline in Acute Cerebral Hemorrhage (MACH) Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Modified Rankin Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Minocycline
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.
干预措施: Minocycline (Drug)
结局指标
主要结局
Modified Rankin Scale
时间窗: 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.
次要结局
- Safety Assessment(90 days)
研究者
Jeffrey Switzer
Associate Professor
Augusta University