| CTRI Number |
CTRI/2025/05/087854 [Registered on: 28/05/2025] Trial Registered Prospectively |
| Last Modified On: |
19/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the efficacy and safety of intravenous hypertonic saline versus mannitol in patients of spontaneous intracranial haemorrhage |
|
Scientific Title of Study
|
Comparison of efficacy and safety profile of intravenous hypertonic saline versus mannitol in patients with spontaneous intracranial haemorrhage - a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanka Samal |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Room number 239, Neurology OPD, AIIMS Bhubaneswar, Sijua, patrapada, bhubaneswar, Khordha ORISSA 751019
Khordha
ORISSA
751019
India |
| Phone |
9868981637 |
| Fax |
|
| Email |
neuro_priyanka@aiimsbhubaneswar.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rituparna Bera |
| Designation |
Senior Resident Neurology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Neurology, 3rd floor, AIIMS Bhubaneswar Khordha ORISSA 751019 India
Khordha
ORISSA
751019
India |
| Phone |
6295113480 |
| Fax |
|
| Email |
rituparnabera2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rituparna Bera |
| Designation |
Senior Resident Neurology |
| Affiliation |
AIIMS Bhubaneswar |
| Address |
Department of Neurology, 3rd floor, AIIMS Bhubaneswar Khordha ORISSA 751019 India
Khordha
ORISSA
751019
India |
| Phone |
6295113480 |
| Fax |
|
| Email |
rituparnabera2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumduma, Bhubaneswar. PIN- 751019 |
|
|
Primary Sponsor
|
| Name |
AIIMS Bhubaneswar |
| Address |
AIIMS Bhubaneswar, Sijua, Patrapada, PO- Dumduma, Bhubaneswar. PIN- 751019 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR RITUPARNA BERA |
AIIMS Bhubaneswar |
Department of Neurology, Neurology OPD in 3rd floor and Emergency services in ground floor, AIIMS Bhubaneswar, Sijua, Patrapada, PO Dumduma, Bhubaneswar Khordha ORISSA
Khordha
ORISSA
Khordha
ORISSA |
6295113480
rituparnabera2012@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee AIIMS Bhubaneswar |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
goup 2 - Injection 3% hypertonoic saline |
group 2 - will receive injection 3% hypertonic saline at a dose of 1.5 - 2 ml/kg 6-8 hourly. |
| Intervention |
group 1- Injection mannitol |
group 1 - will receive injection 20% mannitol at a dose of 0.25 -0.5 gm/kg every 6-8 hourly |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
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. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Change in GCS score |
on day 10 of admission from
baseline at admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
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 effects |
1 & 3 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
25/06/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is a leading cause of mortality,and long term disability worldwide, that significantly impacts global public health . Overall, Intracerebral haemorrhage (ICH) represents approximately10-15%of all strokes worldwide, but imposes significant morbidity& mortality among adults globally,making it significantly impacting global public health. Deleterious outcomes in ICH are a result of primary and secondary pathologic insults. Primary ICH insult is inflicted mostly by mechanical mass effect secondary to clot formation. Further neurological deterioration in ICH patients can occur due to delayed insult secondary to hematoma growth, intraventricular expansion, and peri hematomal edema. Hematomal masseffect, evolving perihematomal edema, and perihematomal growth can result in decreased cerebral perfusion pressure(CPP), increased intracranial pressure (ICP), and herniation .Monitoring and managing ICP is essential inr educing the ris kof brain herniation,ischemia,and further damage. Although decompressive craniectomy (DC) can reduce the mortality rate 38%, intravenous hyperosmolar therapy mannitol or hypertonic normal saline (3%NS) is still an important noninvasiveoption.Both agents work by creating an osmotic gradient that draws fluid out of the brain tissue, but their mechanism & neuroprotective effects may differ. Mannitol is a most commonly used and first–line osmotic agent,considered gold standard for ICP management. But 3% NS due to its osmotic effects and ability to reduce inflammatory responses, is a promising alternative, with several studies showing its enhanced potency over mannitol in patients with traumatic brain injury. But major flaw in those studies was use of varying and non equiosmolar concentration, that makes it difficult to find the most appropriate osmolar agent with salutary effect on ICP. Besid test here is scant literature on the safety,effectiveness,and scope of application of 3% NS in spontaneous ICH.Also, there was scant studies to compare the efficacy of mannitol and hypertonic saline among ICH patients. Hence, this randomized controlled study was designed to comparetheefficacyofequi-osmolarsolutionsof3%NSand 20%mannitol basedonchange inGCS, andother clinical & radiologicalparameters,andfunctionaloutcome |