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A study to see which type of surgery on the skull is better for brain swelling after head injury

Decompressive Craniectomy versus Hinge Craniotomy for Intracranial hypertension in Traumatic Brain Injury - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065004
Enrollment
500
Registered
2024-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Intervention1: Hinge craniotomy: After doing a large craniotomy (diameter greater than 12 cm), the bone flap will be split into multiple pieces (three, usually), and the pieces will then be joined tog

Sponsors

National Institute of Mental Health and Neurosciences (NIMHANS)
Lead Sponsor
National Institute for Health and Care Research
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Closed head injury patients in whom brain swelling is indicative of raised intracranial pressure that is no longer controlled by medical management

Exclusion criteria

Exclusion criteria: Unsurvivable injury Comoborbidities that prevent surgical treatment Previous history of decompressive craniectomy (DC) or cranioplasty where further DC or hinge craniotomy cannot be done.

Design outcomes

Primary

MeasureTime frame
Extended Glasgow Outcome Scale (GOSE)Timepoint: 12 months from injury

Secondary

MeasureTime frame
Reduction in intracranial pressureTimepoint: 24 hours after the intervention (surgery) [if an ICP monitoring was done];Extended Glasgow Outcome Scale (GOSE)Timepoint: One, three, and six months;Wound complicationsTimepoint: 14 days of intervention;Postoperative hydrocephalusTimepoint: 12 months after injury;Timing of cranioplasty (in the DC group)Timepoint: 12 months after injury;Method of storage of the bone flap in the DC groupTimepoint: 12 months of injury;Duration of hospitalisationTimepoint: 12 months of injury

Countries

Brazil, India, Pakistan

Contacts

Public ContactDhaval Shukla

National Institute of Mental Health and Neurosciences (NIMHANS)

neurodhaval@rediffmail.com9898073843

Outcome results

None listed

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