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

CSF Leakage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05792683
• Other study ID #: NEHRIA
• Status: Recruiting
• Phase: N/A
• Start date: February 21, 2023
• Est. completion date: August 21, 2023

Study information

• Verified date: March 2023
• Source: Rawalpindi Medical College
• Contact: Atiq UR [arehman], MBBS
• Phone: 00923344314213
• Email: drnehria[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• CSF Leakage

Intervention

Device:
• lumbar drain
Patient will be placed in the lateral decubitus position; catheter will be inserted by using a Tuohy needle in the interspinous area of lumbar spine. The LD catheter will reach the lumbar subarachnoid space.The remaining part of the drainage kit will be placed along the back of the patient. The catheter insertion site will be sutured and treated with povidone-iodine ointment. Sterile drape will be used to cover the entire external part of the LD. The CSF will be collected within the closed beg. CSF drainage through LD will be around 10 ml per hour or 200-250 ml/day.

Locations

Country	Name	City	State
Pakistan	RMU	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Rawalpindi Medical College

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of active CSF leak in post-traumatic patients with Lumbar drain.	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 .	06 months
Secondary	incidence of recurrence of CSF leaks, meningitis after treatment	After treatment with both methods the incidence of recurrence of CSF leaks and meningitis will be recorded .	with in 06 months