Embolization of the Splenic Artery After Trauma
ELSA-2
2 other identifiers
interventional
250
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2022
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2021
CompletedFirst Posted
Study publicly available on registry
November 22, 2021
CompletedStudy Start
First participant enrolled
May 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
April 24, 2025
April 1, 2025
4.6 years
November 10, 2021
April 21, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Primary Technical Success
The ability to deploy the assigned embolic device in the mid-splenic artery with resultant occlusion of the artery within 15 minutes of deployment.
3 years
Secondary Outcomes (1)
Number of Participants Enrolled within 24 months
24 months
Study Arms (2)
Active Comparator: Splenic artery embolization with vascular embolic coils
ACTIVE COMPARATORDevice: Splenic artery embolization with vascular embolic coils
Active Comparator: Splenic artery embolization with vascular embolic plugs
ACTIVE COMPARATORActive Comparator: Splenic artery embolization with vascular embolic plugs
Interventions
Splenic artery embolization with vascular embolic coils or plugs
Eligibility Criteria
You may qualify if:
- ≥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.
You may not qualify if:
- Inability to obtain informed consent
- ≤ 50kg
- Uncorrectable coagulopathy
- Patient is immunocompromised
- Pregnant
- Breast-feeding
- Non-English speakers
- Prisoners
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Andrew J. Gunnlead
- Penumbra Inc.collaborator
Study Sites (5)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
Prisma Health
Greenville, South Carolina, 29615, United States
The University of Texas Health Science Center at Houston McGovern Medical School
Houston, Texas, 77030, United States
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
November 10, 2021
First Posted
November 22, 2021
Study Start
May 10, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
April 24, 2025
Record last verified: 2025-04