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

NCT ID: NCT05792683

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-21
• Study Completion Date: 2023-08-21

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 .

Conditions

CSF Leakage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Early lumbar drain

30 in this group

Group Type: ACTIVE_COMPARATOR

lumbar drain

Intervention Type: DEVICE

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.

conservative treatment

30 in this group

Group Type: OTHER

lumbar drain

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rawalpindi Medical College

OTHER

Sponsor Role: lead

Responsible Party

Dr Atiq ur Rehman

dr atiq

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Atiq UR [arehman]

Role: PRINCIPAL_INVESTIGATOR

Rawalpindi Medical College

Locations

RMU

Rawalpindi, Punjab Province, Pakistan

Site Status: RECRUITING

Countries

Pakistan

Central Contacts

Atiq UR [arehman], MBBS

Role: CONTACT

Phone: 00923344314213

Email: drnehria@gmail.com

Facility Contacts

Atiq UR rehman, MBBS

Role: primary

Atiq UR [arehman]

Role: backup

Other Identifiers

NEHRIA

Identifier Type: -

Identifier Source: org_study_id