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A clinical trial to study the effect of an additional procedure named basal cisternostomy in head injury patients planned for decompressive craniectomy

A randomized trial to evaluate the role of adjuvant basal cisternostomy in traumatic brain injury patients planned for decompressive craniectomy in a tertiary care center in India. - ABC

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/042144
Enrollment
100
Registered
2022-04-25
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

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: Adjuvant Basal Cisternostomy: In this arm, in head injury patients planned for decompressive craniectomy (standard recommended procedure), an additional procedure of basal cisteronosto

Sponsors

King Georges Medical University
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age 18 years and above presenting with traumatic brain injury having surgically evacuable lesions and brain is bulging after evacuation of hematoma.

Exclusion criteria

Exclusion criteria: 1. Hemodynamic instability (polytrauma cases) 2. Pregnant females 3. Coagulopathy 4. Brain stem dysfunction and signs of irreversible brain damage (b/l fixed dilated pupils)

Design outcomes

Secondary

MeasureTime frame
GCS/GOS at 6 weeks/12 weeksTimepoint: 6 weeks/ 12 weeks;Mid line shift and status of basal cisterns in CT in post op period/on 3rd day post operative /on 7th day post opTimepoint: Postoperative Day 1, Day 3 & Day 7;Mortality within one week/2 weeks/3 weeks (related to TBI sequelae)Timepoint: one week, two weeks & 3 weeks.;No of days on ventilator/ in ICU Timepoint: No of days on ventilator/ in ICU—

Primary

MeasureTime frame
To study intracranial pressure in post operative periodTimepoint: 72 hours—

Countries

India

Contacts

Public ContactDr Sarita Kumari

King Georges Medical University

bkojha@rediffmail.com918076616687

Outcome results

None listed

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