Spontaneous intracerebral hemorrhage (sICH)
Conditions
Interventions
Deferoxamine Mesylate Group:Dosage form, strength, and route of administration of deferoxamine:
Deferoxamine mesylate for injection, strength: 0.5 g. After reconstitution with normal saline, it appear
Placebo Group:A normal saline solution identical in appearance and packaging to the deferoxamine group but without any active pharmaceutical ingredient will be administered according to the same dosin
Sponsors
Huashan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1)Age between 18 and 80 years. 2)Diagnosis of primary, spontaneous, supratentorial intracerebral hemorrhage (ICH). 3)Onset >= 6 hours, and the study drug can be initiated within 24 hours after ICH onset. 4)Hematoma volume between 15 and 35 mL, as measured by neuroimaging. 5)Female participants must be non-pregnant and have no plans for pregnancy during the study period. 6)The participant or legally authorized representative provides written informed consent.
Exclusion criteria
Exclusion criteria: 1)Secondary intracerebral hemorrhage, including arteriovenous malformation (AVM), traumatic hemorrhage, aneurysm, cavernous malformation, etc. 2)Infratentorial ICH. 3)Severe iron deficiency. 4)Serum creatinine >= 2 mg/dL (decompensated renal insufficiency). 5)Coagulation disorders, defined as activated partial thromboplastin time (aPTT) > 40 seconds, international normalized ratio (INR) > 1.3, or concomitant use of direct oral anticoagulants or low–molecular-weight heparin at admission. 6)Pre-ICH modified Rankin Scale (mRS) score >= 2. 7)Deep coma, defined as Glasgow Coma Scale (GCS) = 6 or NIHSS item 1a score of 3. 8)Evidence of irreversible brainstem dysfunction. 9)NIHSS score < 6 at admission. 10)Planned hematoma evacuation surgery before administration of the study drug. 11)Evidence suggesting withdrawal of care is expected within 72 hours. 12)Participants at high risk for acute respiratory distress syndrome (ARDS). 13)Known history of cognitive impairment. 14)History of chronic bronchitis. 15)Any other condition that, in the investigator’s judgment, makes the participant unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a favorable outcome at 180 days after onset (modified Rankin Scale score 0–2), used to comprehensively assess functional status and quality of life.;Number of cases with clinical deterioration requiring surgical treatment for intracerebral hemorrhage; | — |
Secondary
| Measure | Time frame |
|---|---|
| The mRS score at 180 days after onset;The mRS scores at 28 and 90 days after onset.;Health-related quality of life assessments at 28, 90, and 180 days after onset (EuroQol EQ-5D-5L questionnaire);Assessment of basic activities of daily living at 28, 90, and 180 days after onset (Barthel Index).;Changes in hematoma volume and perihematomal edema volume at 7 days after onset (or at discharge, whichever occurs first).;Cognitive function assessment at 7 days after onset.; | — |
Countries
China
Contacts
Public ContactWei Ni
Huashan Hospital, Fudan University
Outcome results
None listed