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Completed NCT05128955

Embolization of the Splenic Artery After Trauma

Conditions: High-grade Splenic Injuries

Sex: All
Ages: 15 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 180
Sponsor: Andrew J. Gunn

Location: University of Alabama at Birmingham Birmingham Alabama

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05128955). StuddyBuddy aggregates publicly available trial information.