CSF LeakageNCT05792683
Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment
A study testing lumbar drain in people with CSF Leakage, run by Rawalpindi Medical College at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- CSF Leakage
- What is being tested?
- lumbar drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Feb 2023to 21 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15-60 years in both genders.
- Patients with craniospinal post traumatic or post operative CSF leakage for more than 24 hours.
Who cannot join
- Patients with comorbid like Cardiovascular, Chronic Kidney Disease, Coagulopathies and Pregnancy
- Previous history of chest or abdominal surgery.
- Previous history of any lumbosacral surgery.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
RMU
Rawalpindi, Punjab Province, 4600
Atiq UR rehman, MBBS, 00923344314213, drnehria@gmail.com
Atiq UR [arehman]
About this study
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.
Read the 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
- Being tested
- lumbar drain
- Medical subject headings
- Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lumbar drainDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Early lumbar drain | Active comparator | 30 in this group Receives: Device: lumbar drain |
| conservative treatment | Other | 30 in this group Receives: Device: lumbar drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 06 months
Secondary outcomes (1)
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 .
Measured: with in 06 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start21 Feb 2023
- Primary completion21 Jul 2023 (estimated)
- Study completion21 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CSF LeakageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ramdomized control trail
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Atiq ur Rehman, Rawalpindi Medical College
- Investigators
- Atiq UR [arehman], Principal investigator, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05792683
- Sponsor's protocol ID
- NEHRIA
- Status last verified
- Mar 2023
- First submitted
- 1 Mar 2023
- Last updated
- 31 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results of study
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment
- ClinicalTrials.gov ID
- NCT05792683
- Acronym / sponsor ID
- NEHRIA
- Conditions
- CSF Leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 21 Feb 2023 (actual)
- Primary completion
- 21 Jul 2023 (estimated)
- Study completion
- 21 Aug 2023 (estimated)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ramdomized control trail
| Arm | Type | Receives |
|---|---|---|
| Early lumbar drain | Active comparator | Device: lumbar drain30 in this group |
| conservative treatment | Other | Device: lumbar drain30 in this group |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 15-60 years in both genders.
- Patients with craniospinal post traumatic or post operative CSF leakage for more than 24 hours.
Key exclusion criteria (3 listed)
- Patients with comorbid like Cardiovascular, Chronic Kidney Disease, Coagulopathies and Pregnancy
- Previous history of chest or abdominal surgery.
- Previous history of any lumbosacral surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lumbar drainPatient 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. | Device | Early lumbar drain, conservative treatment |
Primary outcome
Length of active CSF leak in post-traumatic patients with Lumbar drain.
Time frame: 06 months
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 .
1 secondary outcome
incidence of recurrence of CSF leaks, meningitis after treatment
Time frame: with in 06 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2023.
- Individual participant dataSharing planned: No. Results of study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atiq UR [arehman] principal investigator
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lumbar drain in people with CSF Leakage, run by Rawalpindi Medical College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Atiq UR [arehman], MBBS (00923344314213, drnehria@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of active CSF leak in post-traumatic patients with Lumbar drain. (time frame: 06 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2023.