Actively Recruiting

Phase Not Applicable
Age: 15Years +
All Genders
NCT05128955

Embolization of the Splenic Artery After Trauma

Led by Andrew J. Gunn · Updated on 2025-04-24

250

Participants Needed

5

Research Sites

238 weeks

Total Duration

On this page

Sponsors

A

Andrew J. Gunn

Lead Sponsor

P

Penumbra Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

Our aim is to conduct a multi-center, Bayesian, randomized clinical trial to evaluate the primary technical success of coils and vascular plugs for proximal splenic artery embolization in the setting of high-grade splenic trauma. The investigator has previously demonstrated the feasibility of such a study in a single center pilot trial.

CONDITIONS

Official Title

Embolization of the Splenic Artery After Trauma

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 15 years of age or older
  • Trauma causing Grade III or higher splenic injury confirmed by contrast-enhanced CT
  • Splenic injury planned for non-operative management by attending trauma surgeon and interventional radiologist
  • Decision by interventional radiologist that proximal splenic artery embolization will be performed with treatment method assigned by randomization
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Weighing 50 kg or less
  • Uncorrectable blood clotting problems
  • Being immunocompromised
  • Currently pregnant
  • Currently breastfeeding
  • Non-English speaker
  • Prisoner

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 5 locations

1

University of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

Actively Recruiting

2

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, United States, 27157

Not Yet Recruiting

3

Ohio State University Medical Center

Columbus, Ohio, United States, 43210

Not Yet Recruiting

4

Prisma Health

Greenville, South Carolina, United States, 29615

Not Yet Recruiting

5

The University of Texas Health Science Center at Houston McGovern Medical School

Houston, Texas, United States, 77030

Not Yet Recruiting

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Research Team

A

April Riddle, BS

CONTACT

E

Evan Hudson, BS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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