Trial Outcomes & Findings for A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery (NCT NCT01639833)
NCT ID: NCT01639833
Last Updated: 2014-07-03
Results Overview
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Day 0
Results posted on
2014-07-03
Participant Flow
Participant milestones
| Measure |
Veriset™ Hemostatic Patch
Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat
|
TachoSil®
Topical Hemostat
TachoSil®: Topical Hemostat
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
39
|
41
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Veriset™ Hemostatic Patch
Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat
|
TachoSil®
Topical Hemostat
TachoSil®: Topical Hemostat
|
|---|---|---|
|
Overall Study
Death
|
4
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
Baseline Characteristics
A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery
Baseline characteristics by cohort
| Measure |
Veriset™ Hemostatic Patch
n=45 Participants
Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat
|
TachoSil®
n=45 Participants
Topical Hemostat
TachoSil®: Topical Hemostat
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.5 years
STANDARD_DEVIATION 12.2 • n=93 Participants
|
66.7 years
STANDARD_DEVIATION 13.4 • n=4 Participants
|
67.6 years
STANDARD_DEVIATION 12.7 • n=27 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
61 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=93 Participants
|
44 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=93 Participants
|
45 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Height
|
171.3 centimeters
STANDARD_DEVIATION 9.1 • n=93 Participants
|
170.8 centimeters
STANDARD_DEVIATION 10.4 • n=4 Participants
|
171.1 centimeters
STANDARD_DEVIATION 9.7 • n=27 Participants
|
|
Weight
|
81.67 kilograms
STANDARD_DEVIATION 14.27 • n=93 Participants
|
81.96 kilograms
STANDARD_DEVIATION 17.27 • n=4 Participants
|
81.82 kilograms
STANDARD_DEVIATION 15.75 • n=27 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).
Outcome measures
| Measure |
Veriset™ Hemostatic Patch
n=41 Participants
Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat
|
TachoSil®
n=45 Participants
Topical Hemostat
TachoSil®: Topical Hemostat
|
|---|---|---|
|
Time to Hemostasis (TTH)
|
1.50 minutes
Interval 1.5 to 2.0
|
3.00 minutes
Confidence interval was calculated using the Brookmeyer and Crowley method. 91% of TachoSil® patients achieved hemostasis at 3 minutes and no patient had hemostasis before 3 minutes. The confidence interval of the median time cannot be estimated.
|
SECONDARY outcome
Timeframe: Day 0Population: The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.
The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.
Outcome measures
| Measure |
Veriset™ Hemostatic Patch
n=41 Participants
Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat
|
TachoSil®
n=45 Participants
Topical Hemostat
TachoSil®: Topical Hemostat
|
|---|---|---|
|
Hemostasis at All Treated Bleeding Sites Within 3 Minutes
|
87.8 percentage of participants
Interval 77.8 to 97.8
|
91.1 percentage of participants
Interval 82.8 to 99.4
|
Adverse Events
Veriset™ Hemostatic Patch
Serious events: 13 serious events
Other events: 23 other events
Deaths: 0 deaths
TachoSil®
Serious events: 11 serious events
Other events: 21 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Veriset™ Hemostatic Patch
n=44 participants at risk
Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat
|
TachoSil®
n=45 participants at risk
Topical Hemostat
TachoSil®: Topical Hemostat
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Cardiac arrest
|
4.5%
2/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Low cardiac output syndrome
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Sick sinus syndrome
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Trifascicular block
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Ventricular failure
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
General disorders
Death
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
General disorders
Impaired healing
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
General disorders
Multi-organ failure
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Diverticulitis
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Pneumonia escherichia
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Postoperative wound infection
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Sepsis
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Injury, poisoning and procedural complications
Vascular graft complication
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Investigations
Cardiac output decreased
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Nervous system disorders
Hemianopia
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Nervous system disorders
Hemiparesis
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Renal and urinary disorders
Renal failure
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Haemothorax
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.5%
2/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
2/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Vascular disorders
Haemorrhage
|
2.3%
1/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
2.2%
1/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
Other adverse events
| Measure |
Veriset™ Hemostatic Patch
n=44 participants at risk
Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat
|
TachoSil®
n=45 participants at risk
Topical Hemostat
TachoSil®: Topical Hemostat
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
11.4%
5/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Atrial Fibrillation
|
29.5%
13/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
22.2%
10/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
3/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Psychiatric disorders
Delirium
|
6.8%
3/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
0.00%
0/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
13.6%
6/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
15.6%
7/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
27.3%
12/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
28.9%
13/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
8.9%
4/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
8.9%
4/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/44 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
8.9%
4/45 • Adverse events were collected through the 90 day follow-up visit.
All adverse events were reported, regardless of relationship to study device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place