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Minocycline Accelerates Intracerebral Hemorrhage Absorption

Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05630534
Acronym
MACHA
Enrollment
90
Registered
2022-11-29
Start date
2023-01-01
Completion date
2024-12-31
Last updated
2022-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intracerebral Hemorrhage

Keywords

Minocycline, hematoma absorption

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.

Interventions

DRUGMinocycline

Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne.

OTHERstarch

Use starch capsules as placebo

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine
CollaboratorOTHER
The Second Affiliated Hospital of Jiaxing University
CollaboratorOTHER
Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Improvement in modified Rankin Scale score at 90 days of onset90 daysmodified Rankin Scale score (points ranging from 0 to 6)

Secondary

MeasureTime frameDescription
Number adverse events related to minocycline within 90 days90 daysnausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury, fever

Contacts

Primary ContactReng Ren
renreng1203@zju.edu.cn+8613486111524
Backup ContactSiyi Jiang
8013023@zju.edu.cn+8615257999226

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026