hinge cranioplasty in treatment of malignant intracranial hypertensio

Phase 3

Recruiting

• Conditions: patient with malignant intracranial hypertention.

• Registration Number: IRCT20180515039678N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 14 January 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

patient with diagnosis of malignant intracranial hypertension indicate cerebral decompression despite medical management
hemorrhagic and ischemic infarct of internal carotid territory
patient with diagnosis of unilateral internal carotid territory intracranial hematoma that indicate surgery without coincidence hematoma E.g Subdural hematoma
patient with traumatic unilateral temporal, parietal, frontal subdural hematoma or combination of them in one side even with same side contusion(not need evacuation) with intracranial pressure above 20cmHg or protrusion of brain parenchym out of site of craniectomy

Exclusion Criteria

pregnant women
patient died during first day after operation
occipital or cerebellar infarction (non internal carotid territory)
patient with history of psychosis
concomitant lesion e.g Brain tumor
concomitant cerebrovascular lesion e.g aneurysm
patient without follow up
patient with history of neurological disorder that cause neurological deficit
multiple cerebrovascular accident or multiple hemorrhagic lesion
history of previous cerebrovascular accident
bilateral cerebrovascular accident or bilateral hemorrhage
concomitant subdural hematoma and intracranial hemorrhage
traumatic posterior fossa hematoma
intraventricular hemorrhage
patient with subdural hematoma and glascow coma scale 3 without brain palsation
depressed fracture and patient with dis-usable bone flap
patient who underwent temporal lobectomy
traumatic injury to thoracic, abdomen, pelvic and their content that need intervention

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Short term and long term evaluation of effect of hinge cranioplasty in decreasing intracranial pressure. Timepoint: 5 day - 3 month - 6 month - 1year. Method of measurement: ICP monitoring with subdural catheter in first 5 day - evaluating the patient with Modified Rankin scale and Glasgow Outcome scale in 3 and 6 month and 1year.

Secondary Outcome Measures

Name	Time	Method
ong term quality of life and complication. Timepoint: 3 month - 6 month -1 year. Method of measurement: Modified Rankin scale and Glasgow Outcome scale.