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Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal Aortic Aneurysm Repair

Primary Purpose

Spinal Cord Ischemia

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cerebrospinal Fluid Drain Placement
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Ischemia

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Age ≥18
  2. Undergoing high risk endovascular thoraco-abdominal aortic aneurysm repair, based on aortic coverage length:

2a: Extent I, II, III TAAA 2b: Extent IV TAAA with >5cm coverage above the celiac artery

Exclusion Criteria:

  1. Active prison incarceration
  2. active pregnancy
  3. moribund patients
  4. ruptured aneurysm
  5. coagulopathy precluding CSF drain placement
  6. urgent or emergent aneurysm repairs

Sites / Locations

  • Univeristy of Alabama at Birmingham HospitalRecruiting
  • UMass Memorial Health HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Prophylactic cerebrospinal fluid drain placement

Selective cerebrospinal fluid drain placement

Arm Description

Patients randomized to receive the experimental treatment will have a prophylactic cerebrospinal fluid drain placed prior to their endovascular aortic repair. All components of the endovascular aortic repair are standard of care treatments.

Patients randomized to the control arm of the study will not receive a prophylactic cerebrospinal fluid drain prior to their endovascular aortic repair. Patients will receive a CSF drain post-operative as needed to treat any symptoms of spinal cord ischemia. This arm of the study is current standard of care.

Outcomes

Primary Outcome Measures

Rate of Spinal Cord Ischemia Onset
The primary outcome of this study is the rate of post-operative spinal cord ischemia. Onset of spinal cord ischemia will be defined by any new lower extremity neurologic deficit not attributable to another cause. Details of lower extremity neurologic exam will be collected during physical exam. Motor weakness will be measured using the Muscle Power Scale.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2021
Last Updated
December 15, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
University of Massachusetts, Worcester, The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT04941157
Brief Title
Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal Aortic Aneurysm Repair
Official Title
United States Aortic Research Consortium (ARC) Pilot Study: Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal Aortic Aneurysm Repair
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
University of Massachusetts, Worcester, The University of Texas Health Science Center, Houston

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a pilot study to be performed at the University of Alabama at Birmingham (UAB) and the University of Massachusetts to determine the feasibility and develop the processes for a future randomized controlled trial to evaluate the occurrence of spinal cord ischemia after endovascular thoracoabdominal aneurysm repair using prophylactic cerebrospinal fluid drains versus no pre-emptive drain. The research question to be addressed is as follows: In the setting of a comprehensive spinal cord ischemia prevention protocol, do prophylactic CSF drains decrease the rate of spinal cord ischemia (SCI) in patients undergoing endovascular thoracoabdominal aneurysm repair?
Detailed Description
Endovascular techniques have transformed the management of thoracoabdominal (extending from the chest into the abdomen) aneurysms, with reduced early complications and death rates compared to open aortic repair operations. However, injury to the spinal cord from reduced blood flow, termed spinal cord ischemia (SCI), continues to be a potentially devastating complication of these operations. SCI occurs in 2% to 15% of patients undergoing Thoracic and Thoracoabdominal Endovascular Aneurysm Repair, depending on length of aortic coverage, among other risk factors for SCI1. Paralysis and paraplegia resulting from SCI can be lead to profound long-term disability, as well as increased short and medium-term mortality. Only 25% of patients with permanent paralysis survive to one year due to complications that develop from SCI2. Additionally, SCI has tremendous financial consequences at many levels for the patient and the healthcare system, given the increased length of hospital/rehabilitation stay and the increased use of healthcare resources required for a paralyzed patient. The avoidance of SCI is therefore critically important. Given the impact that SCI has on quality of life and survival after endovascular repair, avoidance of this complication is critical to the clinical success of the operation. A number of strategies are in use to reduce the risk of developing SCI. These include elevation of the mean arterial pressure (blood pressure) to increase blood flow to the spinal cord, maintenance of an appropriate minimum hemoglobin concentration to improve oxygenation, prophylactic cerebrospinal fluid (CSF) drainage, as well as a number of procedural manipulations that are performed to decrease the occurrence of SCI3. CSF drainage is thought to improve spinal cord perfusion pressure by lowering the intraspinous pressure and thus increase the spinal cord perfusion pressure, given that the spinal cord perfusion pressure is the difference between mean arterial blood pressure and intraspinous pressure. Although prophylactic CSF drainage is widely used and conceptually attractive, it remains controversial due to its own inherent risk of complications4. Despite its widespread use, the clinical effectiveness of prophylactic CSF drainage has not been definitively established, and the placement of these drains has a number of potential complications, including life threatening intracranial (brain) bleeding or spinal cord injury due to epidural (ie around the spinal cord) bleeding. There have been three randomized clinical trials of CSF drainage in patients undergoing open thoracoabdominal aortic surgery repair that demonstrated clinical effectiveness of CSF pressure drainage5. While these trials have some bearing on endovascular treatment, the findings are not fully generalizable to endovascular repairs given the inherent differences in the procedures and patient populations. Furthermore, these trials were conducted in the 1990s/early 2000s, and many aspects of perioperative care have changed since then, again limiting the applicability of the findings. SCI has a spectrum of outcomes after it occurs, and may improve immediately with rescue maneuvers, or can lead to permanent paralysis. CSF drains can be placed prophylactically or placed post-operatively only if SCI develops6, which is often referred to as selective CSF drain placement. Prophylactic CSF drains have not been demonstrated to definitively prevent nor mitigate the severity of SCI in endovascular thoracoabdominal aortic repair, and it is not known whether outcomes of prophylactic drains are superior to selective drains7. Thus, many patients treated with prophylactic drains are put at risk for complications of drain placement and may not benefit from placement of the drain. Further, the strategies mentioned above for avoidance of SCI in the setting of potential CSF drain complications have lowered the incidence of SCI to a point where there is equipoise of prophylactic CSF drains versus selective drains, placed postoperatively only if SCI develops. Demonstrative of this equipoise, standard of care is considered to be either prophylactic OR selective drain usage, depending on the surgeon and institution. Given this clinical equipoise, our intention is to evaluate the incidence of and outcomes of SCI with a pre-emptive CSF strategy versus placement only if SCI develops. This is a pilot study to be performed at the University of Alabama at Birmingham (UAB) and the University of Massachusetts (UMass) to determine the feasibility and develop the processes for a future randomized controlled trial to evaluate the occurrence of SCI after endovascular thoracoabdominal aneurysm repair using prophylactic cerebrospinal fluid drains versus no pre-emptive drain. The research question to be addressed is as follows: In the setting of a comprehensive SCI prevention protocol, do prophylactic CSF drains decrease the rate of SCI in patients undergoing endovascular thoracoabdominal aneurysm repair?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Ischemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prophylactic cerebrospinal fluid drain placement
Arm Type
Experimental
Arm Description
Patients randomized to receive the experimental treatment will have a prophylactic cerebrospinal fluid drain placed prior to their endovascular aortic repair. All components of the endovascular aortic repair are standard of care treatments.
Arm Title
Selective cerebrospinal fluid drain placement
Arm Type
No Intervention
Arm Description
Patients randomized to the control arm of the study will not receive a prophylactic cerebrospinal fluid drain prior to their endovascular aortic repair. Patients will receive a CSF drain post-operative as needed to treat any symptoms of spinal cord ischemia. This arm of the study is current standard of care.
Intervention Type
Procedure
Intervention Name(s)
Cerebrospinal Fluid Drain Placement
Intervention Description
Prophylactic CSF Spinal Drain to be placed prior to surgery in patients randomized to the experimental arm of the study
Primary Outcome Measure Information:
Title
Rate of Spinal Cord Ischemia Onset
Description
The primary outcome of this study is the rate of post-operative spinal cord ischemia. Onset of spinal cord ischemia will be defined by any new lower extremity neurologic deficit not attributable to another cause. Details of lower extremity neurologic exam will be collected during physical exam. Motor weakness will be measured using the Muscle Power Scale.
Time Frame
Baseline to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age ≥18 Undergoing high risk endovascular thoraco-abdominal aortic aneurysm repair, based on aortic coverage length: 2a: Extent I, II, III TAAA 2b: Extent IV TAAA with >5cm coverage above the celiac artery Exclusion Criteria: Active prison incarceration active pregnancy moribund patients ruptured aneurysm coagulopathy precluding CSF drain placement urgent or emergent aneurysm repairs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rebecca St. John
Phone
7034749250
Email
rstjohn@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam W Beck, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Univeristy of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca St. John
Email
rstjohn@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Juliet Blakeslee-Carter, MD
Email
jblakesleecarter@uabmc.edu
Facility Name
UMass Memorial Health Hospital
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shauneen Valliere
Email
shauneen.valliere@umassmed.edu
First Name & Middle Initial & Last Name & Degree
Juliet Blakeslee-Carter
Email
jblakesleecarter@uabmc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be collected electronically from UAB powerchart and stored in an encrypted and secure REDCap database (advanced clinical software application for data warehousing and healthcare analytics related to clinical trials) maintained centrally by UAB. Access to data will be limited to remembers of the research team identified on this IRB proposal. All shared data will be deidentified and related to procedural details and clinical outcomes. Data will be shared with the research team at the University of Massachusetts.
IPD Sharing Time Frame
1 month to 1 year
IPD Sharing Access Criteria
Access to data will be limited to remembers of the research team identified on this IRB proposal.

Learn more about this trial

Prophylactic vs Therapeutic Cerebrospinal Fluid Drain Placement During Endovascular Thoracoabdominal Aortic Aneurysm Repair

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