Intracerebral Hemorrhage (ICH)
Conditions
Interventions
The study setting/ Study sites: Sri Jayewardenepura General Hospital, National Hospital of Sri Lanka, Kandy National Hospital, National Hospital – Galle and Colombo South Teaching Hospital.
If rando
Sponsors
The George Institute for Global Health
University of Calgary
Eligibility
Inclusion criteria
Inclusion criteria: • Adult (age (>18 and 10 mL or any volume post-surgery • National Institute of Health Stroke Scale (NIHSS) score >8 • Glasgow coma scale (GCS) >8 • Provide written informed consent by patient (or approved surrogate)
Exclusion criteria
Exclusion criteria: • Secondary cause of haemorrhage (e.g., structural abnormality such as arteriovenous malformation, cerebral aneurysm, tumour, trauma), or haemorrhagic transformation of acute ischaemic stroke • Isolate intraventricular haemorrhage • Chronic Kidney Disease • Very high likelihood of death within 7 days or poor adherence to study treatment or follow-up • Severe comorbid disease that will interfere with outcome assessments (e.g., cancer, chronic airflow disease, heart failure, significant disability) • Women who are pregnant or lactating Exclusion criteria related to use of deferoxamine: • Previous chelation therapy or known hypersensitivity to deferoxamine products; • Severe iron deficiency anaemia (haemoglobin 325 mg of ferrous iron; • Serum creatinine >2 mg/dL; • Patients with known heart failure taking >500 mg of vitamin C Exclusion criteria related to use of colchicine: • Allergic to colchicine • Myelodysplastic hypoplasia, or liver or severe renal failure • Use of medication which may interact with colchicine (strong CYPsA4 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 [From enrollment to the 6 month assessment] | — |
Secondary
| Measure | Time frame |
|---|---|
| Excellent functional neurological outcome (mRS 0-1) at 6 months [From enrollment to the 6 month assessment] Independent functional neurological outcome (mRS 0-2) at 6 months [From enrollment to the 6 month assessment] Health-related quality of life, as measured by the EQ-5D-5L at month 6 [Completed by telephone at the Day 90 assessment (Day 90 outcomes are assessed in a blinded manner)] Ordinal shift in the 7 levels of mRS at 6 months [Done at the 6-month assessment (assessed in a blinded manner)] Disability (mRS 3-5) at 6 months [Done at the 6-month assessment (assessed in a blinded manner)] NIHSS score at Day 7 and Day 14 (or discharge if earlier) [Assessment performed at Day 7 and Day 14 (or discharge if earlier)] PHE at Day 7 and Day 14 (or discharge if earlier) [Day 7 and Day 14 (or discharge if earlier)] Total length of initial hospital stay [Within 6 months after stroke onset] Ambulatory status at hospital discharge [At the time when patient is discharged from enrolling hospital, within 6 months after stroke onset] Place of residence at 6 months [Completed at the 6-month follow-up visit] | — |
Countries
China,Sri Lanka
Contacts
Public ContactDr. Harsha Hemal Gunasekara
Consultant Neurologist
Outcome results
None listed