Minocycline Accelerates Intracerebral Hemorrhage Absorption

NCT ID: NCT05630534

Last Updated: 2022-11-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2024-12-31

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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Minocycline

Intervention Type: DRUG

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

Control（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

Group Type: PLACEBO_COMPARATOR

starch

Intervention Type: OTHER

Use starch capsules as placebo

Interventions

Minocycline

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

Intervention Type: DRUG

starch

Use starch capsules as placebo

Intervention Type: OTHER

Other Intervention Names

Minomycin

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Fourth Affiliated Hospital of Zhejiang University School of Medicine

OTHER

Sponsor Role: collaborator

The Second Affiliated Hospital of Jiaxing University

OTHER

Sponsor Role: collaborator

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Li

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital Zhejiang University School of Medicine

Central Contacts

Reng Ren

Role: CONTACT

renreng1203@zju.edu.cn

+8613486111524

Siyi Jiang

Role: CONTACT

8013023@zju.edu.cn

+8615257999226

Other Identifiers

SAHZhejiangULiMin

Identifier Type: -

Identifier Source: org_study_id