Embolization of the Splenic Artery After Trauma (ELSA-2)

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.

Study Overview

• Status: Recruiting
• Conditions: High-grade Splenic Injuries
• Intervention / Treatment: Device: Splenic artery embolization with vascular embolic coils or plugs

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 Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: April Riddle, BS; Phone Number: 2059346504; Email: ariddle@uabmc.edu
• Study Contact Backup: Name: Evan Hudson, BS; Phone Number: 2059346499; Email: evanhudson@uabmc.edu

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Principal Investigator: Theresa Caridi, MD
      • Contact: Evan Hudson, BS; Phone Number: 2059346499; Email: evanhudson@uabmc.edu
      • Contact: April Riddle, BS; Phone Number: 205-934-6504; Email: ariddle@uabmc.edu
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Not yet recruiting
      • Wake Forest Baptist Medical Center
      • Contact: Heather Hilton; Email: hdoss@wakehealth.edu
      • Principal Investigator: Michael Miller, MD, FSIR
      • Sub-Investigator: Raisa Durrani, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Not yet recruiting
      • Ohio State University Medical Center
      • Contact: Tammi Stein; Email: Tamara.Stein@osumc.edu
      • Principal Investigator: Mina Makary, MD
      • Sub-Investigator: Carrie Sims, MD
      • Sub-Investigator: Henry Wang, MD, MPH, MS
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Not yet recruiting
      • Prisma Health
      • Contact: Aimee Hanvey, MS; Phone Number: 864-797-6528; Email: Aimee.Hanvey@prismahealth.org
      • Contact: Ashley Susan; Email: Susan.Ashley@prismahealth.org
      • Principal Investigator: Mike Devane, MD
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • The University of Texas Health Science Center at Houston McGovern Medical School
      • Contact: Usha Menon, PhD; Phone Number: 713-704-4656; Email: Usha.N.Menon@uth.tmc.edu
      • Contact: Jessica Stephenson; Phone Number: 7137042842; Email: Jessica.Stephenson@uth.tmc.edu
      • Principal Investigator: Ahmed Aal, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: Splenic artery embolization with vascular embolic coils; Device: Splenic artery embolization with vascular embolic coils	Device: Splenic artery embolization with vascular embolic coils or plugs; Splenic artery embolization with vascular embolic coils or plugs
Active Comparator: Active Comparator: Splenic artery embolization with vascular embolic plugs	Device: Splenic artery embolization with vascular embolic coils or plugs; Splenic artery embolization with vascular embolic coils or plugs

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 months

Collaborators and Investigators

• Sponsor: Andrew J. Gunn
• Collaborators: Penumbra Inc.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: November 10, 2021
• First Submitted That Met QC Criteria: November 10, 2021
• First Posted (Actual): November 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 300008343

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No