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

NCT05792683 | Unknown DMC

• 1 other identifier: NEHRIA
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

CSF Leakage

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• incidence of recurrence of CSF leaks, meningitis after treatment

  with in 06 months

Study Arms (2)

Early lumbar drain

ACTIVE COMPARATOR

30 in this group

Device: lumbar drain

conservative treatment

OTHER

30 in this group

Device: lumbar drain

Interventions

lumbar drain 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.

Early lumbar drain; conservative treatment

Eligibility Criteria

• Age: 15 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Rawalpindi Medical College: lead

Study Sites (1)

RMU

Rawalpindi, Punjab Province, 4600, Pakistan

RECRUITING

MeSH Terms

Conditions

Cerebrospinal Fluid Rhinorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid Leak; Neurologic Manifestations; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Rhinorrhea; Signs and Symptoms, Respiratory; Wounds and Injuries

Study Officials

• Atiq UR [arehman]

  Rawalpindi Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Atiq UR [arehman], MBBS

CONTACT

00923344314213; drnehria@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr atiq

Model Details: ramdomized control trail

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 31, 2023
• Study Start: February 21, 2023
• Primary Completion: July 21, 2023
• Study Completion: August 21, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)