Cerebrovascular Disease
Conditions
Interventions
Deferoxamine mesylate only:Deferoxamine mesylate only: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomization and continue for the follo
Colchicine only:Colchicine only: 0.5mg of oral colchicine daily for 30 consecutive days
Both deferoxamine mesylate and colchicine:Both deferoxamine mesylate and colchicine: deferoxamine mesylate at a dose of 32mg/kg/day via intravenous infusion immediately (within 1 hour) post-randomizat
plus 0.5mg of oral colchicine daily for 30 consecutive days
No deferoxamine mesylate and no colchicine:Standard care
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Adult (age =18 years) 2.Diagnosis of presumed spontaneous supratentorial intracerebral haemorrhage, confirmed by brain imaging 3.Presentation to hospital within 24 hours of symptom onset (or last seen well) 4.Haematoma volume =10 mL or any volume post-surgery 5.National Institute of Health Stroke Scale (NIHSS) score >8 6.Glasgow coma scale (GCS) =8 7.Provide written informed consent by patient (or approved surrogate)
Exclusion criteria
Exclusion criteria: 1.Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke 2.Isolate intraventricular haemorrhage 3.Chronic Kidney Disease 4.Serum creatinine >2 mg/dL; 5.Myelodysplastic hypoplasia, or liver or severe renal failure 6.Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up 7.Severe comorbid disease that will interfere with outcome assessments (eg, cancer, chronic airflow disease, heart failure, significant disability) 8.Women who are pregnant or lactating 9.Previous chelation therapy or known hypersensitivity to deferoxamine products; 10.Severe iron deficiency anaemia (haemoglobin 325 mg of ferrous iron; 12.Patients with known heart failure taking >500 mg of vitamin C 13.Allergic to colchicine 14.Use of medication which may interact with colchicine (strong CYP3A4 inhibitors [e.g., ketoconazole] and strong P-glycoprotein inhibitors [e.g., fluconazole])
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mRS scores at 6 months analysed with utility-weights;Place of residence at 6 months ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mortality at 6 months ;Excellent functional neurological outcome (mRS 0-1);Independent functional neurological outcome (mRS 0-2);Health-related quality of life (HRQoL) based on EQ-5D-5L and EQ VAS scores;Ordinal shift of 7 levels of mRS ;Disability (mRS 3-5) at 6 months;Liver and kidney function at Day 7(or discharge if earlier);Perihematomal edema at Day 7 (or discharge if earlier);National Institute of Health Stroke Scale (NIHSS) score at Day 14(or discharge if earlier);Perihematomal edema at Day 14 (or discharge if earlier);Total length of hospital stays within 6 months after stroke onset;Ambulatory status at discharge;SAEs within 6 months; | — |
Countries
China
Contacts
Public ContactYou Chao
West China Hospital of Sichuan University
Outcome results
None listed