A clinical trial to compare the efficacy and safety of intravenous hypertonic saline versus mannitol in patients of spontaneous intracranial haemorrhage

Comparison of efficacy and safety profile of intravenous hypertonic saline versus mannitol in patients with spontaneous intracranial haemorrhage - a randomized controlled trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/05/087854

Enrollment

Registered

2025-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2025-06-24

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

Conditions

Health Condition 1: G819- Hemiplegia, unspecified

Interventions

Intervention1: group 1- Injection mannitol goup 2 - Injection 3% hypertonoic saline: group 1 - will receive injection 20% mannitol at a dose of 0.25 -0.5 gm/kg every 6-8 hourly. group 2 - will receiv

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of age 18 years or older 2. Spontaneous Supratentorial bleed requiring decongestant drugs as per clinician judgement. 3. Not requiring immediate surgery at the time of randomization.

Exclusion criteria

Exclusion criteria: 1. Infratentorial bleed 2. Disability prior to onset of present stroke (pre stroke MRS more than/ equal to 4) 3. Venous strokes 4. Known case of chronic kidney disease 5. Pregnancy and lactation 6. Traumatic brain injury 7. Extradural/ subdural/ subarachnoid haemorrhage 8. Bleeding into brain SOL 9. Patients with terminal illness/ palliation with life expectancy less than / equal to 6 months. 10. Patients undergoing surgery at the time of randomization

Design outcomes

Primary

Measure	Time frame
To assess Change in GCS scoreTimepoint: on day 10 of admission from baseline at admission	—

Secondary

Measure	Time frame
1. To assess Other clinical parameters of raised ICP ( bradycardia, hypertension, respiration variability , pupillary asymmetry, contralateral signs) 2. To assess correlation of raised ICP features with NCCT head parameters ( midline shift/ midbrain herniation/ mass effect) 3. Change in pulsatility index, mean flow velocity as measured by TCD between day 7- 10 of admission from baseline ( wherever possible) 4. Improvement in disability score by Modified Barthel Index scoring and modified rankin scale (at 1 & 3 months) 5. Drugs related adverse effectsTimepoint: 1 & 3 months	—

Measure

Time frame

1. To assess Other clinical parameters of raised ICP ( bradycardia, hypertension, respiration variability , pupillary asymmetry, contralateral signs) 2. To assess correlation of raised ICP features with NCCT head parameters ( midline shift/ midbrain herniation/ mass effect) 3. Change in pulsatility index, mean flow velocity as measured by TCD between day 7- 10 of admission from baseline ( wherever possible) 4. Improvement in disability score by Modified Barthel Index scoring and modified rankin scale (at 1 & 3 months) 5. Drugs related adverse effectsTimepoint: 1 & 3 months

—

Countries

India

Contacts

Public ContactDr Rituparna Bera

AIIMS Bhubaneswar

rituparnabera2012@gmail.com6295113480

Outcome results

None listed

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