Trial Outcomes & Findings for Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events (NCT NCT03621202)
NCT ID: NCT03621202
Last Updated: 2020-12-28
Results Overview
Statistic measures concordance in detecting bleeds between the Saranas EBBMS and post-procedural CT. Cohen suggested the Kappa result be interpreted as follows: values ≤ 0 as indicating no agreement and 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41- 0.60 as moderate, 0.61-0.80 as substantial, and 0.81-1.00 as almost perfect agreement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Up to 8 hours post procedure
Results posted on
2020-12-28
Participant Flow
Participant milestones
| Measure |
Saranas Early Bird Bleed Monitoring System (EBBMS)
Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
|
|---|---|
|
Overall Study
STARTED
|
66
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
Baseline characteristics by cohort
| Measure |
Saranas Early Bird Bleed Monitoring System (EBBMS)
n=60 Participants
Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
|
|---|---|
|
Age, Continuous
|
76 years
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28 kg/m^2
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Hypertension
|
37 Participants
n=5 Participants
|
|
Diabetes
|
25 Participants
n=5 Participants
|
|
Atrial Fibrillation
|
17 Participants
n=5 Participants
|
|
Renal Insufficiency
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 8 hours post procedureStatistic measures concordance in detecting bleeds between the Saranas EBBMS and post-procedural CT. Cohen suggested the Kappa result be interpreted as follows: values ≤ 0 as indicating no agreement and 0.01-0.20 as none to slight, 0.21-0.40 as fair, 0.41- 0.60 as moderate, 0.61-0.80 as substantial, and 0.81-1.00 as almost perfect agreement.
Outcome measures
| Measure |
Saranas Early Bird Bleed Monitoring System (EBBMS)
n=60 Participants
Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
|
|---|---|
|
Cohen's Kappa Coefficient (κ)
|
0.84 proportion of agreement
|
SECONDARY outcome
Timeframe: Up to 8 hours post procedureSensitivity measures the proportion of positives bleed detection events that are correctly identified by the EBBMS as compared to post-procedural computerized tomography.
Outcome measures
| Measure |
Saranas Early Bird Bleed Monitoring System (EBBMS)
n=60 Participants
Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
|
|---|---|
|
Device Sensitivity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
|
60 Participants
|
SECONDARY outcome
Timeframe: Up to 8 hours post procedureSpecificity relates to the EBBMS' ability to correctly reject non-bleeding events as compared to post-procedural computerized tomography.
Outcome measures
| Measure |
Saranas Early Bird Bleed Monitoring System (EBBMS)
n=60 Participants
Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
|
|---|---|
|
Device Specificity in Bleeding Detection of the Saranas EBBMS as Compared to Post-procedural Computerized Tomography
|
75 Percentage
|
Adverse Events
Saranas Early Bird Bleed Monitoring System (EBBMS)
Serious events: 9 serious events
Other events: 28 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Saranas Early Bird Bleed Monitoring System (EBBMS)
n=60 participants at risk
Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
|
|---|---|
|
Cardiac disorders
Clot on right atrium of tricuspid valve
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
CAD with acute ischemia
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Symptomatic anemia
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Hypertension/SOB/Fluid overload
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
Coronary or RV perforation w cardiac tamponade
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Vascular disorders
Prolonged bleeding from left groin
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Vascular disorders
Pseudoaneurysm
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
2:1 High Grade AV Block
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Vascular disorders
CVA / Bleed
|
1.7%
1/60 • Number of events 1 • 5 months
|
Other adverse events
| Measure |
Saranas Early Bird Bleed Monitoring System (EBBMS)
n=60 participants at risk
Saranas Early Bird Bleed Monitoring System (EBBMS): Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
|
|---|---|
|
Cardiac disorders
2:1 High Grade AV Block
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Vascular disorders
A-V Fistula
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Blood and lymphatic system disorders
Blood Loss Anemia
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
Renal and urinary disorders
Acute Kidney Injury
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
Arrhythmia
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
Atrial Fib & RVR
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Back Pain
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
Cardiac disorders
Bradycardia
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Constipation
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
General disorders
CVA
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
Psychiatric disorders
Delirium
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
Gastrointestinal disorders
Dyspepsia
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
EKG Changes
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Renal and urinary disorders
Elevated Creatinine
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Fever 100.8 Unknown Source
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Generalized Pain
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Gron Pain
|
5.0%
3/60 • Number of events 3 • 5 months
|
|
General disorders
Headache
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Gastrointestinal disorders
Hematemesis
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Renal and urinary disorders
Hyperkalemia
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Hypertension
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Hypotension
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
New LBBB
|
8.3%
5/60 • Number of events 5 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Leukocystosis
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
Gastrointestinal disorders
Nausea
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
Cardiac disorders
New Prolonged P-R Interval
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Musculoskeletal and connective tissue disorders
Polyarthralgias
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Vascular disorders
Pseudoaneurysm
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Vascular disorders
R Temporal Artery Bleed
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Right Arm Pain - Generalized
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
Right Upper Extremity Swelling
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
General disorders
SOB & Fluid Retention
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Renal and urinary disorders
Urinary Retention
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
Ventricular Tachycardia
|
1.7%
1/60 • Number of events 1 • 5 months
|
|
Cardiac disorders
Worsening Heart Failure
|
3.3%
2/60 • Number of events 2 • 5 months
|
|
Blood and lymphatic system disorders
Worsening Thrombocytopenia
|
1.7%
1/60 • Number of events 1 • 5 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place