Clinical trial NCT05792683: Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment
Official title: Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CSF Leakage
Lead sponsor: Rawalpindi Medical College
Sponsor class: OTHER
First posted: 2023-03-31
Enrollment: 60
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ramdomized control trail
Primary purpose: TREATMENT

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 .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Length of active CSF leak in post-traumatic patients with Lumbar drain.
timeFrame: 06 months
Secondary outcomes:
measure: incidence of recurrence of CSF leaks, meningitis after treatment
timeFrame: with in 06 months
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: RMU
state: Punjab
Study officials:
affiliation: Rawalpindi Medical College
name: Atiq UR [arehman]
role: PRINCIPAL_INVESTIGATOR
References: