Minocycline Accelerates Intracerebral Hemorrhage Absorption

NCT05630534 | Unknown Phase 1

• 1 other identifier: SAHZhejiangULiMin
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Intracerebral Hemorrhage

Keywords

Minocycline; hematoma absorption

Outcome Measures

Primary Outcomes (1)

• Improvement in modified Rankin Scale score at 90 days of onset

  modified Rankin Scale score (points ranging from 0 to 6)

  90 days

Secondary Outcomes (1)

• Number adverse events related to minocycline within 90 days

  90 days

Study Arms (2)

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

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

Other: starch

Interventions

Minocycline DRUG

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

Also known as: Minomycin

Minocycline

starch OTHER

Use starch capsules as placebo

Control（starch）

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Spontaneous intracerebral hemorrhage by CT scan
• Intracerebral hematoma volume is less than 16ml
• No surgical treatment of hematoma evacuation

You may not qualify if:

• 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)

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: collaborator
• The Second Affiliated Hospital of Jiaxing University: collaborator

MeSH Terms

Conditions

Cerebral Hemorrhage; cyclopia sequence

Interventions

Minocycline; Starch

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Min Li

  Second Affiliated Hospital Zhejiang University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Reng Ren

CONTACT

+8613486111524; renreng1203@zju.edu.cn

Siyi Jiang

CONTACT

+8615257999226; 8013023@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2022
• First Posted: November 29, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share