Effect of dexamethasone in patients with brain hemorrhage

Effect of dexamethasone in patients with primary intracerebral hemorrhage - a pilot prospective randomized open blinded endpoint study (PROBE design).

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/04/051314

Enrollment

100

Registered

2023-04-05

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I610- Nontraumatic intracerebral hemorrhage in hemisphere, subcortical

Interventions

Intervention1: Dexamethasone: Drug: Dexamethasone Dose: 0.4 mg/kg per day in three divided doses (maximum dose of 40 mg/day) administered intravenously or per orally. Duration: 7 days Control Interv

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1. ICH presumed due to etiologies other than hypertension 2. Patients with ICH requiring surgery at the time of recruitment 3. Glasgow coma score 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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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. Timepoint: 3 months	—

Countries

India

Contacts

Public ContactKanukuntla Sai Krishna

AIIMS New Delhi

vasanthapadma123@gmail.com01126594794

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026