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NCT04941157

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

Completed NA Last updated 10 January 2025
What this trial tests

NA trial testing Cerebrospinal Fluid Drain Placement in Spinal Cord Ischemia in 20 participants. Completed in 1 May 2024.

Timeline
1 October 2022
Primary endpoint
1 May 2024
1 May 2024

Quick facts

Lead sponsorUniversity of Alabama at Birmingham
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment20
Start date1 October 2022
Primary completion1 May 2024
Estimated completion1 May 2024
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Alabama at Birmingham

Who can join

Adults 18 to 100, any sex, with Spinal Cord Ischemia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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?

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Prevention and Management of Spinal Cord Ischemia After Aortic Surgery: An Umbrella Review.
    Brotis AG, Kalogeras A, Bareka M, Arnaoutoglou E, et al · · 2025 · cited 1× · PMID 40309856 · DOI 10.3390/brainsci15040409
  2. Spinal cord protection: lessons learned from endovascular repair.
    Tenorio ER, Oderich GS. · · 2023 · cited 1× · PMID 37817855 · DOI 10.21037/acs-2023-scp-0049

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Other University of Alabama at Birmingham trials

Trials by the same sponsor.

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