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

Primary Purpose

CSF Leakage

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
lumbar drain
Sponsored by
Rawalpindi Medical College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CSF Leakage

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • RMURecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Early lumbar drain

conservative treatment

Arm Description

30 in this group

30 in this group

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

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 .

Full Information

First Posted
March 1, 2023
Last Updated
March 19, 2023
Sponsor
Rawalpindi Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT05792683
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 21, 2023 (Actual)
Primary Completion Date
July 21, 2023 (Anticipated)
Study Completion Date
August 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rawalpindi Medical College

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CSF Leakage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ramdomized control trail
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early lumbar drain
Arm Type
Active Comparator
Arm Description
30 in this group
Arm Title
conservative treatment
Arm Type
Other
Arm Description
30 in this group
Intervention Type
Device
Intervention Name(s)
lumbar drain
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of active CSF leak in post-traumatic patients with Lumbar drain.
Description
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 .
Time Frame
06 months
Secondary Outcome Measure Information:
Title
incidence of recurrence of CSF leaks, meningitis after treatment
Description
After treatment with both methods the incidence of recurrence of CSF leaks and meningitis will be recorded .
Time Frame
with in 06 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Atiq UR [arehman], MBBS
Phone
00923344314213
Email
drnehria@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Atiq UR [arehman]
Organizational Affiliation
Rawalpindi Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
RMU
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
4600
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Atiq UR rehman, MBBS
Phone
00923344314213
Email
drnehria@gmail.com
First Name & Middle Initial & Last Name & Degree
Atiq UR [arehman]

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Results of study

Learn more about this trial

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

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