RecruitingNot Applicable

Embolization of the Splenic Artery After Trauma

United States250 participantsStarted 2022-05-10

Plain-language summary

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.

Who can participate

Age range15 Years

SexALL

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Inclusion criteria

✓. ≥15 years of age
✓. Trauma resulting in grade III or higher splenic injury on contrast-enhanced CT
✓. Splenic injury to be treated by non-operative management as decided by attending trauma surgeon and interventional radiologist
✓. The attending interventional radiologist determines that the patient will undergo proximal splenic artery embolization with the specific method to be decided by randomization.

Exclusion criteria

✕. Inability to obtain informed consent
✕. ≤ 50kg
✕. Uncorrectable coagulopathy
✕. Patient is immunocompromised
✕. Pregnant
✕. Breast-feeding
✕. Non-English speakers
✕. Prisoners

What they're measuring

Primary Technical Success

Timeframe: 3 years

Trial details

NCT IDNCT05128955

SponsorAndrew J. Gunn

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12

Contact for this trial

April Riddle, BS

2059346504 ariddle@uabmc.edu

View on ClinicalTrials.gov More High-grade Splenic Injuries trials