Clinical trial NCT05630534: Minocycline Accelerates Intracerebral Hemorrhage Absorption
Official title: Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Intracerebral Hemorrhage
Keywords: Minocycline
hematoma absorption
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
Collaborators: name: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
name: The Second Affiliated Hospital of Jiaxing University
First posted: 2022-11-29
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Improvement in modified Rankin Scale score at 90 days of onset
timeFrame: 90 days
Secondary outcomes:
measure: Number adverse events related to minocycline within 90 days
timeFrame: 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Second Affiliated Hospital Zhejiang University School of Medicine
name: Min Li
role: PRINCIPAL_INVESTIGATOR
References: