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Study of pediatric traumatic brain injuries to establish the appropriate treatment strategies

Study of Evolution of Cerebral Edema, Neuroinflammation and Blood Brain Barrier disruption in Pediatric Traumatic Brain Injuries

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/02/031122
Enrollment
40
Registered
2021-02-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: S061- Traumatic cerebral edema

Interventions

Control Intervention1: Mannitol and Hypertonic Saline: Patients will be randomly allocated into two groups using opaque sealed envelopes (Group A - 3% Hypertonic Saline treatment and Group B - 20% Ma

Sponsors

Nil Applied for
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pediatric patients admitted to Neurosurgery ICU and planned for initial conservative management at admission. GCS Patients presenting within 24 hours of injury Age 0-18 years

Exclusion criteria

Exclusion criteria: Patients with polytrauma (Blunt trauma chest, blunt trauma abdomen, long bone fracture or spine injury) Patients with shock, sepsis, chronic kidney disease, steroid, antiinflammatory drugs or diabetes mellitus History of encephalitis, CNS vasculitis, meningitis, brain abscess, brain tumor or cranial surgery Past history of head injury Patient requiring primary surgery for post-traumatic intracranial hematomas at admission

Design outcomes

Primary

MeasureTime frame
1. â?¢ Comparing effectiveness of Hypertonic Saline and Mannitol will give us the level 1 evidence of superiority between the two to be used after TBI in pediatric population 2. â?¢ After understanding the pathophysiology of cerebral edema with the help of the biomarkers and genetic polymorphism, development of anti-edema measures can be done. Timepoint: 2Years

Secondary

MeasureTime frame
After the development of anti-edema measures, patients can get early treatment and can be prevented from getting worsened.Timepoint: 2 Years

Countries

India

Contacts

Public ContactKaveri Sharma

Neurosurgeon (AIIMS, New Delhi)

drdeepakgupta@gmail.com9811882710

Outcome results

None listed

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