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To compare medical versus surgical treatment for patients with hypertensive intracerebral bleed.

A prospective randomized controlled study of medical versus medicosurgical management for patients with hypertensive supratentorial intracranial bleed.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/12/010750
Enrollment
30
Registered
2017-12-05
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- patients with spontaneous intracerebral bleed with GCS of 4-14

Interventions

Intervention1: medicosurgical: In 2nd treatment arm, patients given both standard medical and surgical treatment for evacuation of hematoma. Control Intervention1: medical arm: In this patients random

Sponsors

King Georges Medical University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 1)Infratentorial hemorrhage or any involvement of the midbrain or lower brainstem 2)Volume of hematoma 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.

Design outcomes

Primary

MeasureTime frame
mortalityTimepoint: 3 months

Secondary

MeasureTime frame
glasgo outcome scaleTimepoint: 3 months;modified Rankin ScaleTimepoint: 3 months

Countries

India

Contacts

Public ContactMachchhindranath Vijay Nilange

king georges medical university

dr.sksingh2k@gmail.com7408433555

Outcome results

None listed

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