Intracerebral Hemorrhage
Conditions
Keywords
Stroke, Acute Intracerebral Hemorrhage, Intracerebral Hemorrhage, Hemorrhagic stroke, Hemorrhage, Minocycline
Brief summary
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
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.
Interventions
DRUGMinocycline
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.
Sponsors
American Heart Association
Augusta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Modified Rankin Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Safety Assessment | 90 days | Adverse events will be asses for 90 days. This will serve as our safety endpoint. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Minocycline: 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. | 8 |
| Control This arm will not receive any minocycline. This arm will receive standard of care treatment. | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Minocycline | Control | Total |
|---|---|---|---|
| Age, Continuous | 62 years STANDARD_DEVIATION 14.6 | 61.8 years STANDARD_DEVIATION 11.5 | 61.9 years STANDARD_DEVIATION 12.7 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 5 Participants | 7 Participants | 12 Participants |
| Sex: Female, Male Male | 3 Participants | 1 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 8 | 0 / 8 |
| other Total, other adverse events | 0 / 8 | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Minocycline | Modified Rankin Scale | 3.5 units on a scale | Standard Deviation 2.3 |
| Control | Modified Rankin Scale | 3.7 units on a scale | Standard Deviation 1.4 |
Secondary
Safety Assessment
Adverse events will be asses for 90 days. This will serve as our safety endpoint.
Time frame: 90 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Minocycline | Safety Assessment | 0 adverse events |
| Control | Safety Assessment | 0 adverse events |