Cerebrospinal Fluid DrainageNCT04505423
Evaluation of Outcomes Related to Cerebrospinal Fluid Drain Placement
An observational study of Cerebrospinal Fluid Drainage, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebrospinal Fluid Drainage
- What is being tested?
- Blind CSF Drain Placement and Fluoroscopy-guided Drain Placement
- Type of treatment
- Surgery or procedure
- How many people
- 302 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Aug 2020to 1 May 2021
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: UNC Hospital System Patients
Who may be able to join
- CSF drain placed from 2010 to present prior to undergoing aortic surgery
Who cannot join
- Patients under 18 years of age
- Patients undergoing emergency procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Outcomes Related to Cerebrospinal Fluid Drains Placed Either With or Without Fluoroscopic Guidance for Aortic Surgery
The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.
Read the detailed description
Patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair are at risk of suffering devastating spinal cord injury (SCI), rendering them with a permanent neurologic deficit, paraplegia, or paraparesis. Despite huge success over the last several decades with the introduction of innovative protective maneuvers, such as the use of cerebrospinal fluid drains (CSFDs), the rate of these complications remains around 5%. Spinal cord perfusion can be compromised during aortic surgery and the intrathecal decompression achieved by CSFDs functions to increase the pressure gradient of blood flow, thereby optimizing spinal cord perfusion during aortic surgery. There are two methods commonly used to place cerebrospinal fluid drains: blind placement and with fluoroscopic guidance. Prior to 2016, CSFDs at UNC hospital were primarily placed without image guidance. However, hospital policy then transitioned to having all CSFDs placed using fluoroscopic guidance. To the investigators' knowledge, there are no reported studies directly comparing clinical outcomes of CSFDs placed by these methods. Given the increased cost and radiation exposure associated with the use of fluoroscopy, a better understanding of comparative outcomes has great potential clinical value. Therefore, the investigators propose to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.
- Conditions
- Cerebrospinal Fluid Drainage
- Being tested
- Blind CSF Drain Placement, Fluoroscopy-guided Drain Placement
- Medical subject headings
- Cerebrospinal Fluid Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blind CSF Drain PlacementProcedure or surgery
CSF Drain placement without fluoroscopic image guidance.
Fluoroscopy-guided Drain PlacementProcedure or surgery
CSF Drain placement utilizing fluoroscopic image guidance.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate and Severity of Complications Related Associated with CSFD placement
The rate and severity of complications associated with CSFD placement with or without fluoroscopic guidance via a chart review. This will be assessed using quantitative methods such as vital signs and lab-work drawn relating to the procedure as well as qualitative variables through clinical notes.
Measured: From admission to discharge, up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start3 Aug 2020
- Primary completion1 May 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebrospinal Fluid DrainageStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- UNC Medical Alumni
- Responsible party
- Sponsor
- Investigators
- Harendra Arora, MD, MBA, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505423
- Sponsor's protocol ID
- 20-0727
- Status last verified
- Feb 2022
- First submitted
- 5 Aug 2020
- Last updated
- 25 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Publications
Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.
PubMed 8433431Safi HJ, Estrera AL, Miller CC, Huynh TT, Porat EE, Azizzadeh A, Meada R, Goodrick JS. Evolution of risk for neurologic deficit after descending and thoracoabdominal aortic repair. Ann Thorac Surg. 2005 Dec;80(6):2173-9; discussion 2179. doi: 10.1016/j.athoracsur.2005.05.060.
PubMed 16305866
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Outcomes Related to Cerebrospinal Fluid Drains Placed Either With or Without Fluoroscopic Guidance for Aortic Surgery
- ClinicalTrials.gov ID
- NCT04505423
- Acronym / sponsor ID
- 20-0727
- Conditions
- Cerebrospinal Fluid Drainage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- UNC Medical Alumni
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 1 May 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 10 Aug 2020 (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.
The purpose of this study is to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.
Detailed description
Patients undergoing thoracoabdominal aortic aneurysm (TAAA) repair are at risk of suffering devastating spinal cord injury (SCI), rendering them with a permanent neurologic deficit, paraplegia, or paraparesis. Despite huge success over the last several decades with the introduction of innovative protective maneuvers, such as the use of cerebrospinal fluid drains (CSFDs), the rate of these complications remains around 5%. Spinal cord perfusion can be compromised during aortic surgery and the intrathecal decompression achieved by CSFDs functions to increase the pressure gradient of blood flow, thereby optimizing spinal cord perfusion during aortic surgery. There are two methods commonly used to place cerebrospinal fluid drains: blind placement and with fluoroscopic guidance. Prior to 2016, CSFDs at UNC hospital were primarily placed without image guidance. However, hospital policy then transitioned to having all CSFDs placed using fluoroscopic guidance. To the investigators' knowledge, there are no reported studies directly comparing clinical outcomes of CSFDs placed by these methods. Given the increased cost and radiation exposure associated with the use of fluoroscopy, a better understanding of comparative outcomes has great potential clinical value. Therefore, the investigators propose to compare the rate and severity of complications associated with CSFD placement either with or without fluoroscopic guidance.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UNC Hospital System Patients
Key inclusion criteria (1 listed)
- CSF drain placed from 2010 to present prior to undergoing aortic surgery
Key exclusion criteria (2 listed)
- Patients under 18 years of age
- Patients undergoing emergency procedures
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 |
|---|---|---|
| Blind CSF Drain PlacementCSF Drain placement without fluoroscopic image guidance. | Procedure or surgery | – |
| Fluoroscopy-guided Drain PlacementCSF Drain placement utilizing fluoroscopic image guidance. | Procedure or surgery | – |
Primary outcome
Rate and Severity of Complications Related Associated with CSFD placement
Time frame: From admission to discharge, up to 2 weeks
The rate and severity of complications associated with CSFD placement with or without fluoroscopic guidance via a chart review. This will be assessed using quantitative methods such as vital signs and lab-work drawn relating to the procedure as well as qualitative variables through clinical notes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
- Background: PubMed 8433431Svensson LG, Crawford ES, Hess KR, Coselli JS, Safi HJ. Experience with 1509 patients undergoing thoracoabdominal aortic operations. J Vasc Surg. 1993 Feb;17(2):357-68; discussion 368-70.
- Background: PubMed 16305866Safi HJ, Estrera AL, Miller CC, Huynh TT, Porat EE, Azizzadeh A, Meada R, Goodrick JS. Evolution of risk for neurologic deficit after descending and thoracoabdominal aortic repair. Ann Thorac Surg. 2005 Dec;80(6):2173-9; discussion 2179. doi: 10.1016/j.athoracsur.2005.05.060.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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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.
Harendra Arora, MD, MBA principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrospinal Fluid Drainage, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 25 Feb 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate and Severity of Complications Related Associated with CSFD placement (time frame: From admission to discharge, up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505423, which also lists 2 linked publications.
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 25 Feb 2022.