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Embolization in Splenic Trauma (ELSA)

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ClinicalTrials.gov Identifier: NCT03613454
Recruitment Status : Recruiting
First Posted : August 3, 2018
Last Update Posted : March 12, 2020
Sponsor:
Information provided by (Responsible Party):
Andrew J. Gunn, University of Alabama at Birmingham

Brief Summary:
Randomized, prospective, feasibility study to begin evaluating the efficacy, safety, and cost of using either coils or vascular plugs (VPs) for proximal splenic artery embolization in the setting of traumatic splenic injury.

Condition or disease Intervention/treatment Phase
Trauma to the Spleen Device: Splenic artery embolization with vascular embolic coils Device: Splenic artery embolization with vascular embolic plugs Not Applicable

Detailed Description:

Splenic preservation rates are improved for participants with high-grade splenic injuries (defined as Grade III-V injuries by the 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 pancreaticomagna artery with either VPs or coils. 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 pancreaticomagna 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 coils or VPs as the embolic agent, both of which are FDA-approved and clinically-available. Coils 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 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Embolization in Splenic Trauma (ELSA)
Actual Study Start Date : February 16, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Splenic artery embolization with vascular embolic coils Device: Splenic artery embolization with vascular embolic coils
Splenic artery embolization with vascular embolic coils

Active Comparator: Splenic artery embolization with vascular embolic plugs Device: Splenic artery embolization with vascular embolic plugs
Splenic artery embolization with vascular embolic plugs




Primary Outcome Measures :
  1. Ability to enroll sufficient participants within 18 months of study initiation [ Time Frame: Through study completion, an average of 1 year ]
    The primary outcome of the study will be enrolling 50 participants in the study within 18 months of study initiation with adequate 30 day follow-up on all participants.


Secondary Outcome Measures :
  1. Technical success of embolization [ Time Frame: Through study completion, an average of 1 year ]
    This outcome will be measured by the ability of the operator to deploy the required embolic with resultant stasis in the splenic artery. This will be compared between the two groups.

  2. Immediate clinical success [ Time Frame: Through study completion, an average of 1 year ]
    This outcome will be measured by the number of intra-procedural complications and compared between the two groups

  3. Delayed clinical success [ Time Frame: Through study completion, an average of 1 year ]
    This outcome will be measured by splenic salvage rate at 30 days and compared between groups.

  4. Fluoroscopy time [ Time Frame: Through study completion, an average of 1 year ]
    The fluoroscopy times used for each embolic will be measured and compared.

  5. Contrast volume [ Time Frame: Through study completion, an average of 1 year ]
    The amount of contrast used during the procedure will be measured for each group and compared.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients presenting to UAB emergency room requiring embolization of the splenic artery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613454


Contacts
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Contact: Andrew J. Gunn, MD 205-996-7115 agunn@uabmc.edu

Locations
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United States, Alabama
University of Alabama at Birmingham Medical Center Recruiting
Birmingham, Alabama, United States, 35249
Contact: Rebecca Lee    205-934-6499    rebeccalee@uabmc.edu   
Principal Investigator: Andrew J Gunn, MD         
Sub-Investigator: Jan Jansen, MD         
Sub-Investigator: Joel Raborn, MD         
Sponsors and Collaborators
University of Alabama at Birmingham
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Responsible Party: Andrew J. Gunn, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03613454    
Other Study ID Numbers: R18-097
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: March 12, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Wounds and Injuries