Intracerebral HemorrhagePhase 1MACHANCT05630534
Minocycline Accelerates Intracerebral Hemorrhage Absorption
A Phase 1 study testing Minocycline and starch in people with Intracerebral Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intracerebral Hemorrhage
- What is being tested?
- Minocycline and starch
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- Spontaneous intracerebral hemorrhage by CT scan
- Intracerebral hematoma volume is less than 16ml
- No surgical treatment of hematoma evacuation
Who cannot join
- 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 locations and contacts
No sites are listed yet.
About this study
Official title: Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)
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.
Read the 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
- Being tested
- Minocycline, starch
- Keywords
- Minocycline, hematoma absorption
- Medical subject headings
- Cerebral Hemorrhage, cyclopia sequence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MinocyclineDrug
Also called Minomycin
Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne.
starchOther
Use starch capsules as placebo
| Study group | Role | What they receive |
|---|---|---|
| Minocycline | Experimental | 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 Receives: Drug: Minocycline |
| Control（starch） | Placebo comparator | 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 Receives: Other: starch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in modified Rankin Scale score at 90 days of onset
modified Rankin Scale score (points ranging from 0 to 6)
Measured: 90 days
Secondary outcomes (1)
Number adverse events related to minocycline within 90 days
nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury, fever
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracerebral HemorrhageStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University
- Responsible party
- Sponsor
- Investigators
- Min Li, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630534
- Sponsor's protocol ID
- SAHZhejiangULiMin
- Acronym
- MACHA
- Status last verified
- Nov 2022
- First submitted
- 6 Nov 2022
- Last updated
- 29 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Keep the IPD, if other researchers need the data, they can email the investigator.
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)
- ClinicalTrials.gov ID
- NCT05630534
- Acronym / sponsor ID
- MACHA / SAHZhejiangULiMin
- Conditions
- Intracerebral Hemorrhage
- Keywords
- Minocycline, hematoma absorption
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Minocycline | Experimental | Drug: MinocyclineThis 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 |
| Control（starch） | Placebo comparator | Other: starchThis 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-80 years old
- Spontaneous intracerebral hemorrhage by CT scan
- Intracerebral hematoma volume is less than 16ml
- No surgical treatment of hematoma evacuation
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MinocyclineAlso: MinomycinMinocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne. | Drug | Minocycline |
| starchUse starch capsules as placebo | Other | Control（starch） |
Primary outcome
Improvement in modified Rankin Scale score at 90 days of onset
Time frame: 90 days
modified Rankin Scale score (points ranging from 0 to 6)
1 secondary outcome
Number adverse events related to minocycline within 90 days
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No. Keep the IPD, if other researchers need the data, they can email the investigator.
Related trials for Intracerebral Hemorrhage
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Expressive Aphasia, Aphasia Following Cerebral Infarction
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
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Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
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Stereotactic Thrombolysis With Tenecteplase for Supratentorial Intracerebral Hemorrhage
Intracerebral Haemorrhage, Minimally Invasive Treatment
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Sleep to Predict Recovery In Unconscious Patients With Acute Brain Injury
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage (ICH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Li principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Minocycline and starch in people with Intracerebral Hemorrhage, run by Second Affiliated Hospital, Zhejiang University, School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Reng Ren (+8613486111524, renreng1203@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in modified Rankin Scale score at 90 days of onset (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2022.