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Minocycline Accelerates Intracerebral Hemorrhage Absorption (MACHA)

Primary Purpose

Intracerebral Hemorrhage

Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Minocycline
starch
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring Minocycline, hematoma absorption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Minocycline

    Control(starch)

    Arm 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

    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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 6, 2022
    Last Updated
    November 18, 2022
    Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05630534
    Brief Title
    Minocycline Accelerates Intracerebral Hemorrhage Absorption
    Acronym
    MACHA
    Official Title
    Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
    Collaborators
    The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Intracerebral Hemorrhage
    Keywords
    Minocycline, hematoma absorption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Minocycline
    Arm Type
    Experimental
    Arm 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
    Arm Title
    Control(starch)
    Arm Type
    Placebo Comparator
    Arm 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
    Intervention Type
    Drug
    Intervention Name(s)
    Minocycline
    Other Intervention Name(s)
    Minomycin
    Intervention Description
    Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne.
    Intervention Type
    Other
    Intervention Name(s)
    starch
    Intervention Description
    Use starch capsules as placebo
    Primary Outcome Measure Information:
    Title
    Improvement in modified Rankin Scale score at 90 days of onset
    Description
    modified Rankin Scale score (points ranging from 0 to 6)
    Time Frame
    90 days
    Secondary Outcome Measure Information:
    Title
    Number adverse events related to minocycline within 90 days
    Description
    nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury, fever
    Time Frame
    90 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reng Ren
    Phone
    +8613486111524
    Email
    renreng1203@zju.edu.cn
    First Name & Middle Initial & Last Name or Official Title & Degree
    Siyi Jiang
    Phone
    +8615257999226
    Email
    8013023@zju.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Min Li
    Organizational Affiliation
    Second Affiliated Hospital Zhejiang University School of Medicine
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Keep the IPD, if other researchers need the data, they can email the investigator.

    Learn more about this trial

    Minocycline Accelerates Intracerebral Hemorrhage Absorption

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