Embolization of the Splenic Artery After Trauma (ELSA-2)
Andrew J. Gunn
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.
Description
Splenic preservation rates are improved for participants with high-grade splenic injuries (defined as Grade III-V injuries by the American Association for the Surgery of Trauma (AAST) guidelines) when non-operative management is supplemented by image-guided, trans-catheter splenic artery embolization (SAE). SAE is currently the standard of care for hemodynamically stable participants with high-grade splenic injuries. In proximal SAE (pSAE), the mid-splenic artery is embolized between the origins of the dorsal pancreatic artery and pancreatica magna artery with either endovascular plugs (VPs) o…
Eligibility
- Age range
- 15+ years
- Sex
- All
- Healthy volunteers
- No
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. N…
Interventions
- DeviceSplenic artery embolization with vascular embolic coils or plugs
Splenic artery embolization with vascular embolic coils or plugs
Locations (5)
- University of Alabama at BirminghamBirmingham, Alabama
- Wake Forest Baptist Medical CenterWinston-Salem, North Carolina
- Ohio State University Medical CenterColumbus, Ohio
- Prisma HealthGreenville, South Carolina
- The University of Texas Health Science Center at Houston McGovern Medical SchoolHouston, Texas