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NCT06363474
Cisternostomy Vs Decompressive Craniectomy for Severe Traumatic Brain Injury
NA trial testing Decompressive Craniectomy in Severe Traumatic Brain Injury in 190 participants. Not yet recruiting.
1 May 2025
Quick facts
| Lead sponsor | University of Health Sciences Lahore |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 190 |
| Start date | 1 May 2024 |
| Primary completion | 1 May 2025 |
| Estimated completion | 1 May 2025 |
Drugs / interventions tested
- Decompressive Craniectomy
- Cisternostomy
Conditions studied
- Severe Traumatic Brain Injury — all drugs for Severe Traumatic Brain Injury →
Sponsor
University of Health Sciences Lahore
Who can join
Under 60, any sex, with Severe Traumatic Brain Injury. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this clinical study is to compare the outcomes of two neurosurgical interventions, Cisternostomy and Decompressive Craniectomy (DC), for the management of severe Traumatic Brain Injury (TBI), assessed using the Glasgow Outcome Scale (GOS). Severe TBI presents challenges in managing intracranial pressure (ICP) and cerebral perfusion, often requiring surgical intervention. DC involves the removal of a section of the skull to reduce ICP, while Cisternostomy, a technique rooted in microsurgery, aims to alleviate brain edema and lower ICP by creating additional space for cerebrospinal fluid (CSF) circulation. This prospective study will be conducted at the Department of Neurosurgery, Punjab Institute of Neurosciences, Lahore. Patients meeting inclusion criteria will be randomized into Group A (DC) and Group B (Cisternostomy) following brain CT scans. Clinical evaluation will include regular follow-ups for 6 months post-surgery, recording data on GOS, duration of mechanical ventilation, ICU, and hospital stays. Analysis will be performed using SPSS 24, comparing outcomes between groups using Chi-square test and t-test. A significance level of p≤0.05 will be applied. It is hypothesized that Cisternostomy, as an adjunct to traditional TBI management, will effectively reduce ICP, resulting in improved GOS and reduced complications postoperatively, including decreased duration of mechanical ventilation and ICU stay, with sustained improvement observed at 6 months
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06363474
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Related trials
Other trials of Decompressive Craniectomy
Trials testing the same drug.
- NCT06776614 — Effectiveness of Surgical Procedures for Acute Cranial Expansion in Traumatic Brain Injury · not yet recruiting
- NCT04261673 — Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma · NA · active not recruiting
Other recruiting trials for Severe Traumatic Brain Injury
Currently open trials in the same condition.
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- NCT05889650 — External Lumbar Drainage to Reduce ICP in Severe TBI: a Phase 1 Clinical Trial · NA · recruiting
- NCT05566431 — Benchmark Evidence Led by Latin America: Trial of Intracranial Pressure - Pediatrics · NA · recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06363474 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Health Sciences Lahore
- Last refreshed: 12 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06363474.
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