FindTrial
Sign In

A trial in head injury patients undergoing brain surgery to test whether clamped drains reduce postoperative complications compared to regular drains.

Comparing the efficacy of using a Passive drain versus Clamped drain in reducing postoperative complications following Decompressive Craniectomy in traumatic brain injury patients - A Randomised Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095204
Enrollment
94
Registered
2025-09-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Health Condition 1: S069- Unspecified intracranial injury

Interventions

Intervention1: Clamped drain: Drain will be clamped after decompressive craniectomy for 2 days Control Intervention1: Unclamped Drain: Drain will not be clamped for 2 days

Sponsors

Dr Shashikant Prasad
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: i. All patients of Isolated TBI requiring DC between the ages of 18-65 years. ii. Legally authorized representative of patient giving consent for surgery.

Exclusion criteria

Exclusion criteria: i. Patients with coagulopathy (International normalized ratio more than 1.5) or thrombocytopenia (platelets less than 100 x 103 / L) ,or recent antiplatelet or anticoagulation s used in the past 7 days. ii. Patients with trivial fall diagnosed to be intracerebral haemorrhage secondary to hypertension. iii. Patients with polytrauma

Design outcomes

Primary

MeasureTime frame
To know the advantages and complications(Subgaleal haematoma, Meningitis, Hydrocephalus, Brain Bulge, Fever ,Surgical site infection, Hematoma and need for reoperation) of usage of Drain versus Clamped drain in DC for traumatic brain injury.Timepoint: Day1 day2 Day3 7th day 1month 3month—

Secondary

MeasureTime frame
To know the feasibility and possible adversities in using drain in comparison to clamped drain in DC for management of traumatic brain injury .Timepoint: 18 MONTHS—

Countries

India

Contacts

Public ContactDr Shashikant Prasad

All India Institute of Medical Science Patna

dranilk@aiimspatna.org9835699103

Outcome results

None listed

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