Minocycline Accelerates Intracerebral Hemorrhage Absorption (MACHA)

Zhejiang University

Status and phase: Not yet enrolling; Phase 1

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Minocycline; Other: starch

Study type: Interventional

Funder types: Other

Identifiers

NCT05630534

SAHZhejiangULiMin

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups, including a placebo group

Minocycline

Experimental group

Description:

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

Treatment:

Drug: Minocycline

Control（starch）

Placebo Comparator group

Description:

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

Treatment:

Other: starch