Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03613454 |
| Other study ID # |
R18-097 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 16, 2019 |
| Est. completion date |
June 30, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 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 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 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.
