Minocycline Accelerates Intracerebral Hemorrhage Absorption

Phase 1

Not yet recruiting

Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary: 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: 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.

Recruitment & Eligibility

Inclusion Criteria

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)

Arm && Interventions

Group	Intervention	Description
Minocycline	Minocycline	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
Control（starch）	starch	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

Primary Outcome Measures

Name	Time	Method
Improvement in modified Rankin Scale score at 90 days of onset	90 days	modified Rankin Scale score (points ranging from 0 to 6)

Secondary Outcome Measures

Name	Time	Method
Number adverse events related to minocycline within 90 days	90 days	nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury, fever

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