RecruitingNot ApplicableNCT05128955
Embolization of the Splenic Artery After Trauma
Embolization of the Splenic Artery After Trauma (ELSA-2)
Sponsor
Andrew J. Gunn
Enrollment
250 participants
Start Date
May 10, 2022
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 15 Years
Inclusion Criteria4
- ≥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 Criteria8
- Inability to obtain informed consent
- ≤ 50kg
- Uncorrectable coagulopathy
- Patient is immunocompromised
- Pregnant
- Breast-feeding
- Non-English speakers
- Prisoners
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Interventions
DEVICESplenic artery embolization with vascular embolic coils or plugs
Splenic artery embolization with vascular embolic coils or plugs
Locations(5)
View Full Details on ClinicalTrials.gov
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NCT05128955