Effect of dexamethasone in patients with brain hemorrhage
- Conditions
- Health Condition 1: I610- Nontraumatic intracerebral hemorrhage in hemisphere, subcortical
- Registration Number
- CTRI/2023/04/051314
- Lead Sponsor
- AIIMS, New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
1. Patients with primary intracerebral hemorrhage(ICH) confirmed on plain CT head
2. Symptom onset within 72 hours
3. Age between 18 and 80 years
4. Volume of bleed 10-30 mL
1. ICH presumed due to etiologies other than hypertension
2. Patients with ICH requiring surgery at the time of recruitment
3. Glasgow coma score <12
4. Co-existing Intraventricular hemorrhage, subarachnoid hemorrhage
5. Bleeding disorder or anticoagulant use in preceding 7 days
6. Previous disabling stroke (mRS 3 and above)
7. Active infection at recruitment
8. Undiagnosed gastrointestinal bleeding
9. Immunocompromised state or currently taking steroids for any other indication
10. Any condition in the understanding of investigator not ideal for usage of steroids
11. Pregnant and lactating mother
12. Refusal of consent
13. Active malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the all-cause mortality in patients with primary intracerebral hemorrhage receiving dexamethasone plus standard of care against patients receiving standard of care onlyTimepoint: 2 weeks
- Secondary Outcome Measures
Name Time Method To compare rates of adverse events including but not limited to hyperglycemia, hypertension, infection, gastrointestinal bleeding, between the groupsTimepoint: 14 days;To compare the disability assessed by modified Rankin Scale(mRS) at 3 months in patients with primary intracerebral hemorrhage receiving dexamethasone against patients receiving standard of care only. <br/ ><br> <br/ ><br>Timepoint: 3 months