Minocycline Accelerates Intracerebral Hemorrhage Absorption

Study Overview
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Brief Summary
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Minocycline has been found to reduce cerebral edema secondary to cerebral hemorrhage, promote hematoma absorption, and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment, but no significant hematoma absorption effect was seen with short duration of drug use. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption.

Detailed Description
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There is a significant increase in the incidence of spontaneous intracerebral hemorrhage, combined with a high mortality rate. Surgical treatment is mainly used to remove intracerebral hematoma with a supratentorial volume greater than 20ml, and most intracerebral hematomas below 20mL are left to absorb on their own, and the absorption time of such hematomas is about 4 to 6 weeks. Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne. It has been found that it can not only reduce iron overload after intracerebral hemorrhage and inhibit neuroinflammation, but also reduce secondary cerebral edema. Some animal experiments have confirmed that it can promote hematoma absorption through iron chelation and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment of intracerebral hemorrhage, but no significant effect has been seen with short duration of drug use. No clinical RCT study has been conducted to confirm its accelerating effect on the absorption of adult intracerebral hematoma. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption, and this study will have important clinical practical value.

Official Title
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Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: Minocycline
* Other: starch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years old Spontaneous intracerebral hemorrhage by CT scan Intracerebral hematoma volume is less than 16ml No surgical treatment of hematoma evacuation Exclusion Criteria: Allergies to tetracycline antibiotics Pregnancy or suspected pregnancy (pregnancy test will be done on women with fertility potential) Hepatic and/or renal insufficiency Glasgow Coma Scale of 5 or less Secondary cerebral hemorrhage caused by trauma, arteriovenous malformation, aneurysm, tumor or other reasons Thrombocytopenia (platelet count<75000/mm3) or coagulation dysfunction (INR>1.4) Incapable to take care of themselves in past life (score of Rankin scale before stroke>2) Signed DNR (Do Not Resuscitate)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocycline<br>This intervention arm will receive oral or intranasal minocycline capsules 100 mg Q12H, first dose 200 mg, start on the fifth day of cerebral hemorrhage, for 14 days | Drug: Minocycline<br>* Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne.<br>* Other names: Minomycin;|
| Placebo Comparator: Control（starch）<br>This arm will receive oral or intranasal administration of identically packaged placebo capsules (starch) 100 mg Q12H, first dose 200 mg, start on the fifth day of cerebral hemorrhage, for 14 days | Other: starch<br>* Use starch capsules as placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in modified Rankin Scale score at 90 days of onset | modified Rankin Scale score (points ranging from 0 to 6) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number adverse events related to minocycline within 90 days | nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury, fever | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minocycline, hematoma absorption