A study to see which type of surgery on the skull is better for brain swelling due to stroke
Phase 3
- Conditions
- Health Condition 1: O- Medical and Surgical
- Registration Number
- CTRI/2024/04/066126
- Lead Sponsor
- ational Institute of Mental Health and Neurosciences (NIMHANS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
A patient with space occupying arterial or venous infarct in whom the neurosurgeon has recommended cranial decompression
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Extended Glasgow Outcome ScaleTimepoint: 12 months from randomisation
- Secondary Outcome Measures
Name Time Method 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