Trial Outcomes & Findings for Embolization in Splenic Trauma (NCT NCT03613454)
NCT ID: NCT03613454
Last Updated: 2021-08-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Through study completion, an average of 1 year
Results posted on
2021-08-11
Participant Flow
Participant milestones
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
COMPLETED
|
23
|
23
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=24 Participants
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=24 Participants
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39 years
n=24 Participants
|
34 years
n=24 Participants
|
38 years
n=48 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=24 Participants
|
7 Participants
n=24 Participants
|
13 Participants
n=48 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=24 Participants
|
17 Participants
n=24 Participants
|
35 Participants
n=48 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
24 participants
n=24 Participants
|
24 participants
n=24 Participants
|
48 participants
n=48 Participants
|
PRIMARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Two participants dropped out due to protocol violation (invalid consent)
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.
Outcome measures
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 Participants
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 Participants
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Number of Participants Who Were Enrolled Within 18 Months of Study Initiation
|
23 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 1 yearPopulation: Two participants dropped out due to protocol violation (invalid consent)
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.
Outcome measures
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 Participants
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 Participants
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Number of Participants With Embolization Success
|
22 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: During the embolization procedure, an average of 1 hourPopulation: Two participants dropped out due to protocol violation (invalid consent)
This outcome will be measured by the number of intra-procedural complications and compared between the two groups
Outcome measures
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 Participants
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 Participants
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Number of Participants With Immediate Complications
|
2 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 30 days after procedurePopulation: Two participants dropped out due to protocol violation (invalid consent)
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.
Outcome measures
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 Participants
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 Participants
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Number of Participants With Splenic Salvage
|
22 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: During the embolization procedure, an average of 1 hourPopulation: Two participants dropped out due to protocol violation (invalid consent)
The radiation exposure during the embolization procedure for each embolic will be measured and compared.
Outcome measures
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 Participants
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 Participants
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Radiation Exposure
|
250 mGy
Interval 172.0 to 671.0
|
380 mGy
Interval 221.0 to 675.0
|
SECONDARY outcome
Timeframe: During the embolization procedure, an average of 1 hourPopulation: Two participants dropped out due to protocol violation (invalid consent)
The amount of contrast used during the procedure will be measured for each group and compared.
Outcome measures
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 Participants
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 Participants
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Contrast Volume
|
54 mL
Interval 41.0 to 60.0
|
60 mL
Interval 50.0 to 75.0
|
Adverse Events
Splenic Artery Embolization With Vascular Embolic Coils
Serious events: 1 serious events
Other events: 1 other events
Deaths: 1 deaths
Splenic Artery Embolization With Vascular Embolic Plugs
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 participants at risk
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 participants at risk
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Surgical and medical procedures
Coil migration
|
4.3%
1/23 • Number of events 1 • Complications were recorded within 30 days from the procedure.
Two participants dropped out due to protocol violation (invalid consent).
|
0.00%
0/23 • Complications were recorded within 30 days from the procedure.
Two participants dropped out due to protocol violation (invalid consent).
|
|
Surgical and medical procedures
Vascular injury
|
0.00%
0/23 • Complications were recorded within 30 days from the procedure.
Two participants dropped out due to protocol violation (invalid consent).
|
4.3%
1/23 • Number of events 1 • Complications were recorded within 30 days from the procedure.
Two participants dropped out due to protocol violation (invalid consent).
|
Other adverse events
| Measure |
Splenic Artery Embolization With Vascular Embolic Coils
n=23 participants at risk
Splenic artery embolization with vascular embolic coils: Splenic artery embolization with vascular embolic coils
|
Splenic Artery Embolization With Vascular Embolic Plugs
n=23 participants at risk
Splenic artery embolization with vascular embolic plugs: Splenic artery embolization with vascular embolic plugs
|
|---|---|---|
|
Surgical and medical procedures
Coil migration
|
4.3%
1/23 • Number of events 1 • Complications were recorded within 30 days from the procedure.
Two participants dropped out due to protocol violation (invalid consent).
|
0.00%
0/23 • Complications were recorded within 30 days from the procedure.
Two participants dropped out due to protocol violation (invalid consent).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place