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

NCT04941157 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-01-10

No results posted yet for this study

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

Interventions

PROCEDURE

Cerebrospinal Fluid Drain Placement

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

Sponsors & Collaborators

  • University of Massachusetts, Worcester

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • University of Alabama at Birmingham

    lead OTHER

Principal Investigators

  • Adam W Beck, MD · University of Alabama at Birmingham

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-01
Primary Completion
2024-05-01
Completion
2024-05-01

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04941157 on ClinicalTrials.gov