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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT05128955
Study groupRoleWhat they receive
Active Comparator: Splenic artery embolization with vascular embolic coilsActive comparatorDevice: 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 plugsActive comparatorActive 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.

  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.

    Measured: 3 years

Secondary outcomes (1)
  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.

  1. First posted22 Nov 2021
  2. Study start10 May 2022
  3. Primary completion22 Apr 2026
  4. Study completion22 Apr 2026

Resources

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)
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

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.

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