Intracerebral Hemorrhage
Conditions
Keywords
Minocycline, hematoma absorption
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.
Interventions
Minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne.
Use starch capsules as placebo
Sponsors
Study design
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in modified Rankin Scale score at 90 days of onset | 90 days | modified Rankin Scale score (points ranging from 0 to 6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number adverse events related to minocycline within 90 days | 90 days | nausea, vomiting, C-diff, hepatic toxicity, dermatitis, anaphylaxis, renal injury, fever |