Intracerebral Hemorrhage
Conditions
Interventions
Minocycline placebo-control group:Oral Minocycline placebo
Minocycline treatment group:Oral Minocycline hydrochloride capsules
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.CT-confirmed spontaneous supratentorial intracerebral hemorrhage; 2.Aged 18 to 80 years; 3.Within 48 hours of symptom onset; 4.Hematoma volume 15–40 mL; 5.NIHSS score 8–24, with item 1a <= 2; 6.Signed informed consent by the patient or legal representative.
Exclusion criteria
Exclusion criteria: 1.Secondary intracerebral hemorrhage (traumatic, tumor-related, vascular malformation, aneurysm, coagulation disorder, etc.); 2.Intraventricular hemorrhage filling one entire lateral ventricle, third ventricle, or fourth ventricle, or more than half of two lateral ventricles; 3.Significant subarachnoid hemorrhage (Fisher grade >= 3) or subdural hemorrhage; 4.Patients with uncontrollable hypertension or those at high risk of hematoma expansion indicated by imaging signs; 5.Progressive neurological or other severe systemic diseases; 6.Planned surgical intervention for the intracerebral hemorrhage; 7.Pre-stroke disability (modified Rankin Scale score > 1); 8.Severe cardiac insufficiency (NYHA Class III-IV), severe liver disease (ALT or AST > 3 times the normal upper limit value), severe renal insufficiency (serum creatinine > 2 times the normal upper limit value, or glomerular filtration rate 1.5); 10.Allergy or intolerance to minocycline or other tetracycline antibiotics; 11.History of pseudomembranous enteritis or antibiotic-associated enteritis; 12.Use of tetracycline antibiotics within the past week; 13.Intracranial or spinal surgery within the past 3 months; 14.Any major surgery or severe trauma within the past month; 15.Females who are pregnant, within 30 days postpartum, or in the lactation period; 16.Participated in other interventional clinical trials within the past 3 months; 17.Inability to obtain signed informed consent from the patient or representative; 18.Other conditions that are not suitable for participating in this clinical trial, such as inability to understand and/or follow the research procedures due to mental, cognitive, emotional, or physical disorders, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of mRS score 0-3;Serious adverse events (SAE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Combined vascular events;mRS score;Perihematomal blood-brain barrier permeability;Changes in NIHSS score compared with baseline score;Adverse events (AE);Changes in Glasgow Coma Scale score compared with baseline score;Early neurological deterioration;Hematoma expansion or rebleeding;Changes in hs-CRP level compared with baseline level;Volume of Perihematomal Edema (PHE);EQ-5D-5L utility score;Recurrent stroke;Changes in the levels of venous neuroinflammation indicators (IL, TNF-a, TGF-ß, NFL, etc.) compared with baseline levels;Any bleeding events;Antibiotic-associated diarrhea, enteritis, and constipation; | — |
Countries
China
Contacts
Public ContactXingquan Zhao
Beiiing TianTan Hospital, Capital Medical University
Outcome results
None listed