Actively Recruiting
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
Eligibility Criteria
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
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
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
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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