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Embolization in Splenic Trauma

Embolization in Splenic Trauma (ELSA)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03613454
Acronym
ELSA
Enrollment
48
Registered
2018-08-03
Start date
2019-02-16
Completion date
2021-06-30
Last updated
2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma to the Spleen

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.

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 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.

Interventions

DEVICESplenic artery embolization with vascular embolic coils

Splenic artery embolization with vascular embolic coils

DEVICESplenic artery embolization with vascular embolic plugs

Splenic artery embolization with vascular embolic plugs

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients presenting to the University of Alabama at Birmingham (UAB) emergency room requiring embolization of the splenic artery

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Who Were Enrolled Within 18 Months of Study InitiationThrough study completion, an average of 1 yearThe 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

MeasureTime frameDescription
Number of Participants With Embolization SuccessThrough study completion, an average of 1 yearThis 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.
Number of Participants With Immediate ComplicationsDuring the embolization procedure, an average of 1 hourThis outcome will be measured by the number of intra-procedural complications and compared between the two groups
Number of Participants With Splenic Salvage30 days after procedureThis outcome will be measured by splenic salvage rate at 30 days and compared between groups. Splenic salvage was defined as the absence of splenectomy in the medical record or per patient report.
Radiation ExposureDuring the embolization procedure, an average of 1 hourThe radiation exposure during the embolization procedure for each embolic will be measured and compared.
Contrast VolumeDuring the embolization procedure, an average of 1 hourThe amount of contrast used during the procedure will be measured for each group and compared.

Countries

United States

Participant flow

Participants by arm

ArmCount
Splenic Artery Embolization With Vascular Embolic Coils
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
24
Splenic Artery Embolization With Vascular Embolic Plugs
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
24
Total48

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation10

Baseline characteristics

CharacteristicSplenic Artery Embolization With Vascular Embolic PlugsTotalSplenic Artery Embolization With Vascular Embolic Coils
Age, Continuous34 years38 years39 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
24 participants48 participants24 participants
Sex: Female, Male
Female
7 Participants13 Participants6 Participants
Sex: Female, Male
Male
17 Participants35 Participants18 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
1 / 231 / 23
other
Total, other adverse events
1 / 230 / 23
serious
Total, serious adverse events
1 / 231 / 23

Outcome results

Primary

Number of Participants Who Were Enrolled Within 18 Months of Study Initiation

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.

Time frame: Through study completion, an average of 1 year

Population: Two participants dropped out due to protocol violation (invalid consent)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Splenic Artery Embolization With Vascular Embolic CoilsNumber of Participants Who Were Enrolled Within 18 Months of Study Initiation23 Participants
Splenic Artery Embolization With Vascular Embolic PlugsNumber of Participants Who Were Enrolled Within 18 Months of Study Initiation23 Participants
Secondary

Contrast Volume

The amount of contrast used during the procedure will be measured for each group and compared.

Time frame: During the embolization procedure, an average of 1 hour

Population: Two participants dropped out due to protocol violation (invalid consent)

ArmMeasureValue (MEDIAN)
Splenic Artery Embolization With Vascular Embolic CoilsContrast Volume54 mL
Splenic Artery Embolization With Vascular Embolic PlugsContrast Volume60 mL
Secondary

Number of Participants With Embolization Success

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.

Time frame: Through study completion, an average of 1 year

Population: Two participants dropped out due to protocol violation (invalid consent)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Splenic Artery Embolization With Vascular Embolic CoilsNumber of Participants With Embolization Success22 Participants
Splenic Artery Embolization With Vascular Embolic PlugsNumber of Participants With Embolization Success20 Participants
Secondary

Number of Participants With Immediate Complications

This outcome will be measured by the number of intra-procedural complications and compared between the two groups

Time frame: During the embolization procedure, an average of 1 hour

Population: Two participants dropped out due to protocol violation (invalid consent)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Splenic Artery Embolization With Vascular Embolic CoilsNumber of Participants With Immediate Complications2 Participants
Splenic Artery Embolization With Vascular Embolic PlugsNumber of Participants With Immediate Complications1 Participants
Secondary

Number of Participants With Splenic Salvage

This outcome will be measured by splenic salvage rate at 30 days and compared between groups. Splenic salvage was defined as the absence of splenectomy in the medical record or per patient report.

Time frame: 30 days after procedure

Population: Two participants dropped out due to protocol violation (invalid consent)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Splenic Artery Embolization With Vascular Embolic CoilsNumber of Participants With Splenic Salvage22 Participants
Splenic Artery Embolization With Vascular Embolic PlugsNumber of Participants With Splenic Salvage23 Participants
Secondary

Radiation Exposure

The radiation exposure during the embolization procedure for each embolic will be measured and compared.

Time frame: During the embolization procedure, an average of 1 hour

Population: Two participants dropped out due to protocol violation (invalid consent)

ArmMeasureValue (MEDIAN)
Splenic Artery Embolization With Vascular Embolic CoilsRadiation Exposure250 mGy
Splenic Artery Embolization With Vascular Embolic PlugsRadiation Exposure380 mGy

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026