Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2022-05-10
2026-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Active Comparator: Splenic artery embolization with vascular embolic coils
Device: Splenic artery embolization with vascular embolic coils
Splenic artery embolization with vascular embolic coils or plugs
Splenic artery embolization with vascular embolic coils or plugs
Active Comparator: Splenic artery embolization with vascular embolic plugs
Active Comparator: Splenic artery embolization with vascular embolic plugs
Splenic artery embolization with vascular embolic coils or plugs
Splenic artery embolization with vascular embolic coils or plugs
Interventions
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Splenic artery embolization with vascular embolic coils or plugs
Splenic artery embolization with vascular embolic coils or plugs
Eligibility Criteria
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Inclusion Criteria
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
2. ≤ 50kg
3. Uncorrectable coagulopathy
4. Patient is immunocompromised
5. Pregnant
6. Breast-feeding
7. Non-English speakers
8. Prisoners
15 Years
ALL
No
Sponsors
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Penumbra Inc.
INDUSTRY
Andrew J. Gunn
OTHER
Responsible Party
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Andrew J. Gunn
Associate Professor
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Prisma Health
Greenville, South Carolina, United States
The University of Texas Health Science Center at Houston McGovern Medical School
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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000533374
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
300008343
Identifier Type: -
Identifier Source: org_study_id
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