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

NCT04941157 | Completed DMC

• 1 other identifier: IRB-300006588
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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?

Conditions

Spinal Cord Ischemia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 1 year

Study Arms (2)

Prophylactic cerebrospinal fluid drain placement

EXPERIMENTAL

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.

Procedure: Cerebrospinal Fluid Drain Placement

Selective cerebrospinal fluid drain placement

NO INTERVENTION

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.

Interventions

Cerebrospinal Fluid Drain Placement PROCEDURE

Prophylactic CSF Spinal Drain to be placed prior to surgery in patients randomized to the experimental arm of the study

Prophylactic cerebrospinal fluid drain placement

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18
• Undergoing high risk endovascular thoraco-abdominal aortic aneurysm repair, based on aortic coverage length:
• a: Extent I, II, III TAAA 2b: Extent IV TAAA with \>5cm coverage above the celiac artery

You may not qualify if:

• Active prison incarceration
• active pregnancy
• moribund patients
• ruptured aneurysm
• coagulopathy precluding CSF drain placement
• urgent or emergent aneurysm repairs

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• University of Massachusetts, Worcester: collaborator
• The University of Texas Health Science Center, Houston: collaborator

Study Sites (2)

Univeristy of Alabama at Birmingham Hospital

Birmingham, Alabama, 35213, United States

Location

UMass Memorial Health Hospital

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Spinal Cord Ischemia

Condition Hierarchy (Ancestors)

Spinal Cord Vascular Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Adam W Beck, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 28, 2021
• Study Start: October 1, 2022
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: January 10, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 1 month to 1 year
• Access Criteria: Access to data will be limited to remembers of the research team identified on this IRB proposal.

Locations

US (2)