Minocycline Accelerates Intracerebral Hemorrhage Absorption

Intracerebral Hemorrhage Clinical Trial

— MACHA  

Official title:

Study of Minocycline Accelerated Intracerebral Hemorrhage Absorption (MACHA)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05630534
• Other study ID #: SAHZhejiangULiMin
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Reng Ren
• Phone: +8613486111524
• Email: renreng1203[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

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

Other:
• starch
Use starch capsules as placebo

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University	The Fourth Affiliated Hospital of Zhejiang University School of Medicine, The Second Affiliated Hospital of Jiaxing University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in modified Rankin Scale score at 90 days of onset	modified Rankin Scale score (points ranging from 0 to 6)	90 days
Secondary	Number adverse events related to minocycline within 90 days	nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury, fever	90 days