To compare medical versus surgical treatment for patients with hypertensive intracerebral bleed.
- Conditions
- Health Condition 1: null- patients with spontaneous intracerebral bleed with GCS of 4-14
- Registration Number
- CTRI/2017/12/010750
- Lead Sponsor
- King Georges Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
1)Supratentorial spontaneous ICH
2)Age 18-60 years.
3)Volume of hematoma >30 cc
4)Motor response M5 or lower
5)Symptoms less than 72 hours prior to diagnostic CT scan (an unknown time of symptom onset is exclusionary)
6)Negative pregnancy test
7)GCS 4-14
1)Infratentorial hemorrhage or any involvement of the midbrain or lower brainstem
2)Volume of hematoma < 30 cc
3)Symptoms more than 72 hours prior to diagnostic CT scan
4)M6 motor response / GCS 3 or 15
5)Coagulation disorders
6)Any concurrent serious illness that would interfere with the safety of surgery.
7)Ruptured aneurysm, AVM, any other vascular anomaly or suspicion thereof.
8)Greater than 60 years (higher incidence of amyloid)
9)Under 18 years of age (high incidence of occult vascular malformation)
10)Pregnant (positive pregnancy test) or lactating females (likelihood of altered coagulation function associated with the high estrogen/progesterone state)
11)Patientâ??s attendants not giving consent for surgery or inclusion in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method mortalityTimepoint: 3 months
- Secondary Outcome Measures
Name Time Method glasgo outcome scaleTimepoint: 3 months;modified Rankin ScaleTimepoint: 3 months