High-grade Splenic InjuriesELSA-2NCT05128955
Embolization of the Splenic Artery After Trauma
A study testing Splenic artery embolization with vascular embolic coils or plugs in people with High-grade Splenic Injuries, run by Andrew J. Gunn at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- High-grade Splenic Injuries
- What is being tested?
- Splenic artery embolization with vascular embolic coils or plugs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 5 sitesUnited States
- Study dates
- 10 May 2022to 22 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ≥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.
Who cannot join
- Inability to obtain informed consent
- ≤ 50kg
- Uncorrectable coagulopathy
- Patient is immunocompromised
- Pregnant
- Breast-feeding
- Non-English speakers
- Prisoners
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Ohio State University Medical Center
Columbus, Ohio, 43210
Prisma Health
Greenville, South Carolina, 29615
The University of Texas Health Science Center at Houston McGovern Medical School
Houston, Texas, 77030
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Embolization of the Splenic Artery After Trauma (ELSA-2)
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.
Read the detailed 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) or endovascular coils (EC). This reduces the intra-splenic arterial pressure which allows the parenchyma time to heal. Splenic perfusion is maintained via a collateral pathway consisting of flow from the splenic artery proximal to the site of embolization through the smaller dorsal pancreatic artery to the transverse pancreatic artery to the pancreatica magna artery which then delivers a slower, smaller amount of blood to the splenic artery distal to the site of embolization. Additionally, collateral supply from the short gastric and gastroepiploic arteries helps to protect the spleen from infarction and/or abscess formation.
pSAE is most often accomplished using either VPs or ECs as the embolic agent, both of which are FDA-approved and clinically-available. ECs have a long history of efficacy and safety for embolization and are thus familiar embolic agents to most endovascular specialists. Further, coils large enough to embolize the mid-splenic artery can be deployed through a standard micro-catheter, which means they can be used in even the most tortuous splenic arteries. However, multiple coils may need to be deployed in the same patient to achieve hemostasis in the mid-splenic artery that may increase their overall cost, iodinated contrast use, procedural time, and the radiation exposure to the participant and medical staff. Additionally, given the high-flow nature of the splenic artery, even an appropriately sized coil may migrate distally. A typical pSAE using coils will involve the deployment of one helical coil followed by multiple packing coils until hemostasis is achieved. VPs attempt to overcome the limitations of coils. For example, the deployment of a single VP can typically provide hemostasis in the mid-splenic artery which theoretically reduces procedural time, contrast load, and radiation exposure. Despite this, VPs are usually more expensive than coils on a per unit basis and are usually less familiar devices to endovascular specialists. Another drawback of VPs is that they cannot be deployed through a standard micro-catheter but rather require the advancement of a larger, stiffer 0.035 inch system into the mid-splenic artery. This may limit their use in very tortuous splenic arteries. Currently, the selection of embolic agent for pSAE is primarily based on operator experience and preference. The embolic efficacy, technical success, and cost of using coils compared to VPs has been evaluated in other diseases; yet, to the best of our knowledge, these embolic agents have never been compared for their use in pSAE, much less in a randomized, prospective fashion.
- Conditions
- High-grade Splenic Injuries
- Being tested
- Splenic artery embolization with vascular embolic coils or plugs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splenic artery embolization with vascular embolic coils or plugsDevice
Splenic artery embolization with vascular embolic coils or plugs
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Splenic artery embolization with vascular embolic coils | Active comparator | Device: Splenic artery embolization with vascular embolic coils Receives: Device: Splenic artery embolization with vascular embolic coils or plugs |
| Active Comparator: Splenic artery embolization with vascular embolic plugs | Active comparator | Active Comparator: Splenic artery embolization with vascular embolic plugs Receives: Device: Splenic artery embolization with vascular embolic coils or plugs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (1)
Number of Participants Enrolled within 24 months
The primary outcome of the study will be to enroll 250 participants within 24 months of study initiation with adequate 30 day follow-up on all participants.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2021
- Study start10 May 2022
- Primary completion22 Apr 2026
- Study completion22 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-grade Splenic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew J. Gunn
- Sponsor type
- University, hospital or other
- Collaborators
- Penumbra Inc.
- Responsible party
- Sponsor-investigator, Andrew J. Gunn, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05128955
- Sponsor's protocol ID
- 300008343
- Other IDs
- Penumbra, Inc.
- Acronym
- ELSA-2
- Status last verified
- Jun 2026
- First submitted
- 10 Nov 2021
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embolization of the Splenic Artery After Trauma (ELSA-2)
- ClinicalTrials.gov ID
- NCT05128955
- Acronym / sponsor ID
- ELSA-2 / 300008343
- Conditions
- High-grade Splenic Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Andrew J. GunnUniversity, hospital or other
- Collaborators
- Penumbra Inc.
- Study start
- 10 May 2022 (actual)
- Primary completion
- 22 Apr 2026 (actual)
- Study completion
- 22 Apr 2026 (actual)
- First posted
- 22 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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) or endovascular coils (EC). This reduces the intra-splenic arterial pressure which allows the parenchyma time to heal. Splenic perfusion is maintained via a collateral pathway consisting of flow from the splenic artery proximal to the site of embolization through the smaller dorsal pancreatic artery to the transverse pancreatic artery to the pancreatica magna artery which then delivers a slower, smaller amount of blood to the splenic artery distal to the site of embolization. Additionally, collateral supply from the short gastric and gastroepiploic arteries helps to protect the spleen from infarction and/or abscess formation.
pSAE is most often accomplished using either VPs or ECs as the embolic agent, both of which are FDA-approved and clinically-available. ECs have a long history of efficacy and safety for embolization and are thus familiar embolic agents to most endovascular specialists. Further, coils large enough to embolize the mid-splenic artery can be deployed through a standard micro-catheter, which means they can be used in even the most tortuous splenic arteries. However, multiple coils may need to be deployed in the same patient to achieve hemostasis in the mid-splenic artery that may increase their overall cost, iodinated contrast use, procedural time, and the radiation exposure to the participant and medical staff. Additionally, given the high-flow nature of the splenic artery, even an appropriately sized coil may migrate distally. A typical pSAE using coils will involve the deployment of one helical coil followed by multiple packing coils until hemostasis is achieved. VPs attempt to overcome the limitations of coils. For example, the deployment of a single VP can typically provide hemostasis in the mid-splenic artery which theoretically reduces procedural time, contrast load, and radiation exposure. Despite this, VPs are usually more expensive than coils on a per unit basis and are usually less familiar devices to endovascular specialists. Another drawback of VPs is that they cannot be deployed through a standard micro-catheter but rather require the advancement of a larger, stiffer 0.035 inch system into the mid-splenic artery. This may limit their use in very tortuous splenic arteries. Currently, the selection of embolic agent for pSAE is primarily based on operator experience and preference. The embolic efficacy, technical success, and cost of using coils compared to VPs has been evaluated in other diseases; yet, to the best of our knowledge, these embolic agents have never been compared for their use in pSAE, much less in a randomized, prospective fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Splenic artery embolization with vascular embolic coils | Active comparator | Device: Splenic artery embolization with vascular embolic coils or plugsDevice: Splenic artery embolization with vascular embolic coils |
| Active Comparator: Splenic artery embolization with vascular embolic plugs | Active comparator | Device: Splenic artery embolization with vascular embolic coils or plugsActive Comparator: Splenic artery embolization with vascular embolic plugs |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- ≥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.
Key exclusion criteria (8 listed)
- Inability to obtain informed consent
- ≤ 50kg
- Uncorrectable coagulopathy
- Patient is immunocompromised
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Splenic artery embolization with vascular embolic coils or plugsSplenic artery embolization with vascular embolic coils or plugs | Device | Active Comparator: Splenic artery embolization with vascular embolic coils, Active Comparator: Splenic artery embolization with vascular embolic plugs |
Primary outcome
Primary Technical Success
Time frame: 3 years
The ability to deploy the assigned embolic device in the mid-splenic artery with resultant occlusion of the artery within 15 minutes of deployment.
1 secondary outcome
Number of Participants Enrolled within 24 months
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splenic artery embolization with vascular embolic coils or plugs in people with High-grade Splenic Injuries, run by Andrew J. Gunn at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Technical Success (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.