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A study to see which type of surgery on the skull is better for brain swelling due to stroke

Decompressive craniectomy versus hinge craniotomy for intracranial hypertension in stroke - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/066126
Enrollment
500
Registered
2024-04-23
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Hinge craniotomy: The craniotomy skull flap will be cut into three or more parts and will be joined together loosely with either sutures or metal plates and then kept back loosely on th

Sponsors

National Institute of Mental Health and Neurosciences (NIMHANS)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: A patient with space occupying arterial or venous infarct in whom the neurosurgeon has recommended cranial decompression

Exclusion criteria

Exclusion criteria: Unknown patient Patient with polytrauma patient with spinal cord injury Patient requiring decompression following failed thrombectomy for stroke Unsurvivable injury Cardiac arrest Severe medical or surgical comorbidities that would affect the outcomes of the patient independantly

Design outcomes

Primary

MeasureTime frame
Extended Glasgow Outcome ScaleTimepoint: 12 months from randomisation

Secondary

MeasureTime frame
Control of intracranial pressureTimepoint: 24 hours after surgery;Economic evaluationTimepoint: 12 months;Further cranial surgery after randomisationTimepoint: Within two weeks;Glasgow coma scale at dischargeTimepoint: Usually 14 days after surgery (7-30 days);Serious adverse effects and surgical complications during current admission.Timepoint: Usually 7- 30 days;Subsequent re-admission to the neurosurgical unit for cranioplastyTimepoint: Within 12 months of surgery

Countries

Brazil, India, United Kingdom

Contacts

Public ContactDhaval Shukla

NIMHANS, Bengaluru

neurodhaval@rediffmail.com9898073843

Outcome results

None listed

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