Cardiovascular Disease
Conditions
Brief summary
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
Interventions
BIOLOGICALEVARREST™
EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
BIOLOGICALTopical hemostat
Equine collagen with Human Fibrinogen and Human Thrombin
OTHERStandard of Care
SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Sponsors
Ethicon, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects ≥18 years of age, requiring an elective or urgent, open aortic surgical procedure utilizing cardiopulmonary bypass; * Subjects must be willing to participate in the study and provide written informed consent.
Exclusion criteria
* Subjects with known intolerance to blood products or to one of the components of the study product or unwilling to receive blood products; * Exposure to another investigational drug or device in a clinical trial within 30 days prior to surgery or anticipated in the 30 day follow up period after surgery. * Female subjects who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | Intraoperative, 3 minutes following treatment application | Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | Intraoperative, 6 minutes following treatment application | The number of subjects achieving hemostatic success at 6 minutes following treatment application. |
| Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | Intraoperative, 10 minutes following treatment application | Number of subjects achieving hemostatic success at 10 minutes following treatment application. |
| Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | Intra-operative, prior initiation of final chest wall closure. Safety Issue: | The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment |
| Number of Participants With Adverse Events Potentially Related to Thrombotic Events | 30 days (+ 14 days) following surgery | The number of subjects with an adverse event potentially related to a thrombotic event |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from September 17, 2012 through September 3, 2013 at hospitals and medical centers throughout the United States.
Participants by arm
| Arm | Count |
|---|---|
| EVARREST Fibrin Sealant Patch EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts - a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin. | 13 |
| Topical Hemostat Equine collagen sponge with Human Fibrinogen and Human Thrombin | 18 |
| Standard of Care (SoC) SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. | 11 |
| Total | 42 |
Baseline characteristics
| Characteristic | EVARREST Fibrin Sealant Patch | Total | Standard of Care (SoC) | Topical Hemostat |
|---|---|---|---|---|
| Age, Continuous Age | 56.0 Years STANDARD_DEVIATION 15.1 | 58.8 Years STANDARD_DEVIATION 14 | 60.5 Years STANDARD_DEVIATION 15.4 | 59.8 Years STANDARD_DEVIATION 12.9 |
| BMI Category Morbidly obese | 2 Participant | 4 Participant | 1 Participant | 1 Participant |
| BMI Category Normal | 5 Participant | 16 Participant | 4 Participant | 7 Participant |
| BMI Category Obese | 3 Participant | 12 Participant | 4 Participant | 5 Participant |
| BMI Category Overweight | 3 Participant | 10 Participant | 2 Participant | 5 Participant |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 4 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 2 Participants | 11 Participants | 2 Participants | 7 Participants |
| Race/Ethnicity, Customized White/Caucasian | 9 Participants | 26 Participants | 6 Participants | 11 Participants |
| Sex: Female, Male Female | 4 Participants | 9 Participants | 2 Participants | 3 Participants |
| Sex: Female, Male Male | 9 Participants | 33 Participants | 9 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 13 / 13 | 18 / 18 | 11 / 11 |
| serious Total, serious adverse events | 3 / 13 | 10 / 18 | 6 / 11 |
Outcome results
Primary
Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur
Time frame: Intraoperative, 3 minutes following treatment application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | 12 Participants |
| Topical Hemostat | Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | 6 Participants |
| Standard of Care (SoC) | Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application. | 5 Participants |
95% CI: [0.64, 0.998]
95% CI: [0.133, 0.59]
95% CI: [0.167, 0.766]
Secondary
Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment
The number of subjects who, after the initial establishment of TBS hemostasis at 3 minutes, had re-bleeding requiring treatment
Time frame: Intra-operative, prior initiation of final chest wall closure. Safety Issue:
Population: Subjects who established TBS hemostasis at 3 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | 0 Participants |
| Topical Hemostat | Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | 5 Participants |
| Standard of Care (SoC) | Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment | 0 Participants |
Secondary
Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application
Number of subjects achieving hemostatic success at 10 minutes following treatment application.
Time frame: Intraoperative, 10 minutes following treatment application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | 12 Participants |
| Topical Hemostat | Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | 12 Participants |
| Standard of Care (SoC) | Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application | 8 Participants |
Secondary
Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application
The number of subjects achieving hemostatic success at 6 minutes following treatment application.
Time frame: Intraoperative, 6 minutes following treatment application
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | 12 Participants |
| Topical Hemostat | Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | 11 Participants |
| Standard of Care (SoC) | Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application | 7 Participants |
Secondary
Number of Participants With Adverse Events Potentially Related to Thrombotic Events
The number of subjects with an adverse event potentially related to a thrombotic event
Time frame: 30 days (+ 14 days) following surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Number of Participants With Adverse Events Potentially Related to Thrombotic Events | 0 Participants |
| Topical Hemostat | Number of Participants With Adverse Events Potentially Related to Thrombotic Events | 2 Participants |
| Standard of Care (SoC) | Number of Participants With Adverse Events Potentially Related to Thrombotic Events | 2 Participants |