Embolization of the splenic artery after trauma
Embolization of the Splenic Artery After Trauma (ELSA-2)
NA · University of Alabama at Birmingham · NCT05128955
This study is testing whether using coils or vascular plugs to block blood flow in the splenic artery can help patients with serious spleen injuries heal better and keep their spleens.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | University of Alabama at Birmingham (other) |
| Drugs / interventions | radiation |
| Locations | 5 sites (Birmingham, Alabama and 4 other locations) |
| Trial ID | NCT05128955 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of coils and vascular plugs for proximal splenic artery embolization in patients with high-grade splenic injuries. It is a multi-center, Bayesian, randomized trial that builds on previous pilot studies demonstrating the feasibility of this approach. The study focuses on improving splenic preservation rates by utilizing image-guided, trans-catheter embolization techniques in hemodynamically stable patients. Participants will be randomly assigned to receive either endovascular plugs or coils as embolic agents to reduce intra-splenic arterial pressure and promote healing.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 15 and older with grade III or higher splenic injuries who are suitable for non-operative management.
Not a fit: Patients who are immunocompromised, pregnant, or have uncorrectable coagulopathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management and outcomes for patients with high-grade splenic injuries.
How similar studies have performed: Previous studies have shown promising results with similar embolization techniques, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Birmingham, Alabama and 4 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
- Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States (NOT_YET_RECRUITING)
- Ohio State University Medical Center — Columbus, Ohio, United States (NOT_YET_RECRUITING)
- Prisma Health — Greenville, South Carolina, United States (NOT_YET_RECRUITING)
- The University of Texas Health Science Center at Houston McGovern Medical School — Houston, Texas, United States (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: April Riddle, BS
- Email: ariddle@uabmc.edu
- Phone: 2059346504
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: High-grade Splenic Injuries