Cardiac Surgical Procedures, Hemorrhage
Conditions
Brief summary
The objective of this study is to assess the safety and effectiveness of Veriset™ Hemostatic Patch in cardiovascular procedures by comparing Veriset™ Hemostatic Patch to TachoSil® in subjects undergoing open cardiovascular surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or CABG.
Interventions
DEVICEVeriset Hemostatic Patch
Topical hemostat
DEVICETachoSil®
Topical Hemostat
Sponsors
Medtronic - MITG
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has provided informed consent. * Subject is ≥18 years of age. * Subject is scheduled for surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or coronary artery bypass graft (CABG) where a topical hemostatic agent would be used to control bleeding via an open approach. * Subject is willing and able to comply with all aspects of the treatment and evaluation schedule. * Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death. * Subject has a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin. * Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding. * Subject has an estimated life expectancy of less than 6 months. * Subject is unwilling to receive blood products. * Subject is scheduled for another planned cardiovascular surgery, and subsequent surgery would jeopardize previous application of study treatment. * The subject has participated in another investigational drug or device research study within 30 days of enrollment.
Exclusion criteria
* Subject has an appropriate Target Bleeding Site (TBS) defined as an area of bleeding on the aorta or coronary vessels where hemostasis by conventional methods is ineffective or impractical, and thus necessitates the use of a topical hemostatic agent. * TBS Bleeding is Type 2 (Oozing/Mild) or 3 (Moderate). * It is possible to hold pressure on Veriset™ Hemostatic Patch or TachoSil® for at least 3 minutes. * Incidental finding of any other pre-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis (TTH) | Day 0 | Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at All Treated Bleeding Sites Within 3 Minutes | Day 0 | The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application. |
Countries
Belgium, Germany, Latvia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Veriset™ Hemostatic Patch Topical Hemostat
Veriset™ Hemostatic Patch: Topical hemostat | 45 |
| TachoSil® Topical Hemostat
TachoSil®: Topical Hemostat | 45 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | TachoSil® | Total | Veriset™ Hemostatic Patch |
|---|---|---|---|
| Age, Continuous | 66.7 years STANDARD_DEVIATION 13.4 | 67.6 years STANDARD_DEVIATION 12.7 | 68.5 years STANDARD_DEVIATION 12.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 45 Participants | 89 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 170.8 centimeters STANDARD_DEVIATION 10.4 | 171.1 centimeters STANDARD_DEVIATION 9.7 | 171.3 centimeters STANDARD_DEVIATION 9.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 44 Participants | 89 Participants | 45 Participants |
| Sex: Female, Male Female | 13 Participants | 29 Participants | 16 Participants |
| Sex: Female, Male Male | 32 Participants | 61 Participants | 29 Participants |
| Weight | 81.96 kilograms STANDARD_DEVIATION 17.27 | 81.82 kilograms STANDARD_DEVIATION 15.75 | 81.67 kilograms STANDARD_DEVIATION 14.27 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 23 / 44 | 21 / 45 |
| serious Total, serious adverse events | 13 / 44 | 11 / 45 |
Outcome results
Primary
Time to Hemostasis (TTH)
Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).
Time frame: Day 0
Population: The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Veriset™ Hemostatic Patch | Time to Hemostasis (TTH) | 1.50 minutes |
| TachoSil® | Time to Hemostasis (TTH) | 3.00 minutes |
Secondary
Hemostasis at All Treated Bleeding Sites Within 3 Minutes
The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.
Time frame: Day 0
Population: The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Veriset™ Hemostatic Patch | Hemostasis at All Treated Bleeding Sites Within 3 Minutes | 87.8 percentage of participants |
| TachoSil® | Hemostasis at All Treated Bleeding Sites Within 3 Minutes | 91.1 percentage of participants |