← Back to Clinical Trials
Recruiting NCT05128955

Embolization of the Splenic Artery After Trauma

Trial Parameters

Condition High-grade Splenic Injuries
Sponsor Andrew J. Gunn
Study Type INTERVENTIONAL
Phase N/A
Enrollment 250
Sex ALL
Min Age 15 Years
Max Age N/A
Start Date 2022-05-10
Completion 2026-12
Interventions
Splenic artery embolization with vascular embolic coils or plugs

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. ≥15 years of age 2. Trauma resulting in grade III or higher splenic injury on contrast-enhanced CT 3. Splenic injury to be treated by non-operative management as decided by attending trauma surgeon and interventional radiologist 4. 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: 1. Inability to obtain informed consent 2. ≤ 50kg 3. Uncorrectable coagulopathy 4. Patient is immunocompromised 5. Pregnant 6. Breast-feeding 7. Non-English speakers 8. Prisoners

Related Trials