CompletedNot Applicable

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

United States20 participantsStarted 2022-10-01

Plain-language 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?

Who can participate

Age range18 Years – 100 Years

SexALL

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Inclusion criteria

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

Exclusion criteria

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

What they're measuring

Rate of Spinal Cord Ischemia Onset

Timeframe: Baseline to 1 year

Trial details

NCT IDNCT04941157

SponsorUniversity of Alabama at Birmingham

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-01

View on ClinicalTrials.gov More Spinal Cord Ischemia trials