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Clinical Trials/NCT05792683
NCT05792683
Recruiting
Not Applicable

Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment

Rawalpindi Medical College1 site in 1 country60 target enrollmentStarted: February 21, 2023Last updated:
ConditionsCSF Leakage

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
Rawalpindi Medical College
Enrollment
60
Locations
1
Primary Endpoint
Length of active CSF leak in post-traumatic patients with Lumbar drain.

Overview

Brief Summary

As limited data is available locally and internationally regarding early Lumbar drain and its effect on duration of CSF leak we have decided to compare it conservative treatment. By providing CSF an alternative route for drainage, the fistula site will remain dry. Leakage site won't be facing CSF pressure, and this will promote early healing of the wound.

Detailed Description

Cerebrospinal fluid (CSF)leak is caused by communication between the subarachnoid space and the air-filled spaces of the middle ear or para nasal sinuses and sometimes skin. CSF leaks can be divided into two types ,traumatic and non traumatic. The traumatic CSF leaks further divided into accidental and iatrogenic (post surgical procedures) 1. Almost 80% of CSF leaks are due to road traffic accidents, fall from heights and firearms injuries to brain and spine, 16% are iatrogenic, and 4% are non-traumatic 1,2. More than 50% of traumatic CSF leaks are evident within the first 02 days, 70% within the first week, and almost all present within the first 3 months [2,3]. It is estimated that in patients with skull base fracture 10-30% develops CSF leaks and 2% of all traumatic head injuries are associated with CSF leaks [4].With the help of conservative treatment most of the CSF leaks stop within 7-10 days 1,5. When the CSF leak doesn't stop after 7-10 days, a lumbar drainage (LD) is suggested3,7. LD(lumbar drain) is a recommended treatment method for the CSF leaks in skull base and spinal trauma, the indications for LD(lumbar drain ) placement are still controversial ,LD(lumbar drain) effect on early CSF leakage cessation is still arguable 2,3. Traumatic CSF leaks duration can be reduced by early( lumbar drain) placement . At tertiary level particularly in public hospital, our study will be helpful to document the benefits of early lumbar drain (LD) in traumatic CSF leakage patients and their hospital stay. This will also help to reduce the ambiguity regarding the protocol for early lumbar drain (LD) placement .

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
15 Years to 60 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age between 15-60 years in both genders.
  • Patients with craniospinal post traumatic or post operative CSF leakage for more than 24 hours.

Exclusion Criteria

  • Patients with comorbid like Cardiovascular, Chronic Kidney Disease, Coagulopathies and Pregnancy
  • Previous history of chest or abdominal surgery.
  • Previous history of any lumbosacral surgery.

Outcomes

Primary Outcomes

Length of active CSF leak in post-traumatic patients with Lumbar drain.

Time Frame: 06 months

Lumbar drain will reduce the CSF pressure on the wound which will lead to early healing of CSF leak sight.it will reduce the duration of CSF leak in post traumatic patients .

Secondary Outcomes

  • incidence of recurrence of CSF leaks, meningitis after treatment(with in 06 months)

Investigators

Sponsor
Rawalpindi Medical College
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr Atiq ur Rehman

dr atiq

Rawalpindi Medical College

Study Sites (1)

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