N/A
N=48
Embolization in Splenic Trauma
Trauma to the Spleen
Bottom Line
View on ClinicalTrials.gov: NCT03613454 ↗Enrolled (actual)
48
Serious AEs
4.4%
Results posted
May 2021
Primary outcome: Primary: Number of Participants Who Were Enrolled Within 18 Months of Study Initiation — 23; 23 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Splenic artery embolization with vascular embolic coils (Device); Splenic artery embolization with vascular embolic plugs (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Alabama at Birmingham
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Were Enrolled Within 18 Months of Study Initiation |
23; 23 | — |
| SECONDARY Number of Participants With Embolization Success |
22; 20 | — |
| SECONDARY Number of Participants With Immediate Complications |
2; 1 | — |
| SECONDARY Number of Participants With Splenic Salvage |
22; 23 | — |
| SECONDARY Radiation Exposure |
250; 380 | — |
| SECONDARY Contrast Volume |
54; 60 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patients presenting to the University of Alabama at Birmingham (UAB) emergency room requiring embolization of the splenic artery
Data sourced from ClinicalTrials.gov (NCT03613454). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.