Hemorrhage, Soft Tissue Bleeding
Conditions
Keywords
Hemostasis
Brief summary
The objective of this study is to evaluate the clinical utility of EVARREST™ Fibrin Sealant Patch (Fibrin Pad) as an adjunct to hemostasis in soft tissue bleeding during intra-abdominal (stomach area), retroperitoneal (hip and stomach area), pelvic (hip area) and non-cardiac thoracic (chest area) surgery.
Detailed description
This is a randomized, controlled single-center study observing the clinical utility of EVARREST™ against standard of care (SoC) in controlling soft tissue bleeding. Standard of care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care. All subjects will be followed post-operatively through discharge and at 30 (+/-14) days. Approximately 150 qualified subjects undergoing intra-abdominal, retroperitoneal, pelvic and non-cardiac thoracic surgery requiring adjunctive support for hemostasis for soft tissue bleeding will be enrolled in the study. Subjects will be randomized on a 1:1 basis, EVARREST™ vs. SoC.
Interventions
BIOLOGICALEVARREST™ Fibrin Sealant Patch
EVARREST™ Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
OTHERStandard of Care
Standard of Care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care.
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 intra-abdominal, retroperitoneal, pelvic or non-cardiac thoracic surgical procedures; * Subjects or legally authorized representative must be willing to participate in the study and provide written informed consent. * Presence of an appropriate Target Bleeding Site as identified intra-operatively by the surgeon;
Exclusion criteria
* Subjects with known intolerance to blood products or to one of the components of EVARREST™ or unwilling to receive blood products; * Female subjects who are pregnant or nursing. * TBS is from a large defect in an artery or vein where the injured vascular wall requires repair and maintenance of vessel patency or where there would be persistent exposure of EVARREST™ to blood flow and/or pressure during absorption of the product; * TBS with major arterial bleeding requiring suture or mechanical ligation; * TBS within a contaminated or infected area of the body; * Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine; * Subjects with any intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Parameter - Incidence of Thromboembolic Events | Surgery up until the 30 day follow-up | Number of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started. |
| Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS) | Surgery up until the 30 day follow-up | Number of subjects experiencing a post-operative bleeding event specifically related to the target bleeding site (TBS) and as reported in the adverse events/serious adverse event safety set. Safety set consisting of all subjects on whom procedure is started. |
| Safety Parameter - Incidence of Increase Blood Fibrinogen Level | Surgery up until the 30 day follow-up | Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started. |
Other
| Measure | Time frame | Description |
|---|---|---|
| This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Intraoperative | This product is easy and quick to prepare for application to the target bleeding site. |
| This Product is Easy to Apply to a Variety of Bleeding Sites. | Intraoperative | This product is easy to apply to a variety of bleeding sites. |
| This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Intraoperative | This product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from July 2, 2013 through August 13, 2015 at a single center in 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. | 75 |
| Standard of Care (SoC) Manual compression with or without a topical absorbable hemostat | 75 |
| Total | 150 |
Baseline characteristics
| Characteristic | EVARREST Fibrin Sealant Patch | Standard of Care (SoC) | Total |
|---|---|---|---|
| Age, Customized 18 to < 50 years | 23 Participants | 20 Participants | 43 Participants |
| Age, Customized 50 to < 65 years | 31 Participants | 35 Participants | 66 Participants |
| Age, Customized 65 to < 75 years | 15 Participants | 16 Participants | 31 Participants |
| Age, Customized >= 75 yeatrs | 6 Participants | 4 Participants | 10 Participants |
| BMI Category Morbidly obese | 11 Participants | 8 Participants | 19 Participants |
| BMI Category Normal | 10 Participants | 11 Participants | 21 Participants |
| BMI Category Obese | 37 Participants | 34 Participants | 71 Participants |
| BMI Category Overweight | 15 Participants | 22 Participants | 37 Participants |
| BMI Category Underweight | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Black or African American | 5 Participants | 9 Participants | 14 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White / Caucasian | 69 Participants | 66 Participants | 135 Participants |
| Sex: Female, Male Female | 42 Participants | 39 Participants | 81 Participants |
| Sex: Female, Male Male | 33 Participants | 36 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 75 | 10 / 75 |
| serious Total, serious adverse events | 3 / 75 | 7 / 75 |
Outcome results
Primary
Safety Parameter - Incidence of Increase Blood Fibrinogen Level
Number of subjects experiencing an increase in blood fibrinogen from the safety set consisting of all subjects on whom procedure is started.
Time frame: Surgery up until the 30 day follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Safety Parameter - Incidence of Increase Blood Fibrinogen Level | 3 Participants |
| Standard of Care (SoC) | Safety Parameter - Incidence of Increase Blood Fibrinogen Level | 1 Participants |
Primary
Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS)
Number of subjects experiencing a post-operative bleeding event specifically related to the target bleeding site (TBS) and as reported in the adverse events/serious adverse event safety set. Safety set consisting of all subjects on whom procedure is started.
Time frame: Surgery up until the 30 day follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS) | 0 Participants |
| Standard of Care (SoC) | Safety Parameter - Incidence of Post-operative Bleeding Events Specifically Related to the Target Bleeding Site (TBS) | 0 Participants |
Primary
Safety Parameter - Incidence of Thromboembolic Events
Number of subjects experiencing a thromboembolic event as reported in the adverse events/serious adverse event safety set. the Safety set consists of all subjects on whom procedure is started.
Time frame: Surgery up until the 30 day follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| EVARREST Fibrin Sealant Patch | Safety Parameter - Incidence of Thromboembolic Events | 2 Participants |
| Standard of Care (SoC) | Safety Parameter - Incidence of Thromboembolic Events | 7 Participants |
Other Pre-specified
This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site.
This product is easy and quick to prepare for application to the target bleeding site.
Time frame: Intraoperative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVARREST Fibrin Sealant Patch | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Disagree | 0 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Agree | 12 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Neutral | 0 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Strongly Agree | 62 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Strongly Disagree | 1 Participants |
| Standard of Care (SoC) | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Strongly Agree | 14 Participants |
| Standard of Care (SoC) | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Strongly Disagree | 5 Participants |
| Standard of Care (SoC) | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Disagree | 0 Participants |
| Standard of Care (SoC) | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Neutral | 46 Participants |
| Standard of Care (SoC) | This Product is Easy and Quick to Prepare for Application to the Target Bleeding Site. | Agree | 10 Participants |
Other Pre-specified
This Product is Easy to Apply to a Variety of Bleeding Sites.
This product is easy to apply to a variety of bleeding sites.
Time frame: Intraoperative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVARREST Fibrin Sealant Patch | This Product is Easy to Apply to a Variety of Bleeding Sites. | Strongly Disagree | 1 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Apply to a Variety of Bleeding Sites. | Neutral | 0 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Apply to a Variety of Bleeding Sites. | Strongly Agree | 64 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Apply to a Variety of Bleeding Sites. | Agree | 10 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Apply to a Variety of Bleeding Sites. | Not applicable | 0 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Apply to a Variety of Bleeding Sites. | Disagree | 0 Participants |
| Standard of Care (SoC) | This Product is Easy to Apply to a Variety of Bleeding Sites. | Not applicable | 1 Participants |
| Standard of Care (SoC) | This Product is Easy to Apply to a Variety of Bleeding Sites. | Agree | 9 Participants |
| Standard of Care (SoC) | This Product is Easy to Apply to a Variety of Bleeding Sites. | Strongly Disagree | 5 Participants |
| Standard of Care (SoC) | This Product is Easy to Apply to a Variety of Bleeding Sites. | Disagree | 1 Participants |
| Standard of Care (SoC) | This Product is Easy to Apply to a Variety of Bleeding Sites. | Strongly Agree | 13 Participants |
| Standard of Care (SoC) | This Product is Easy to Apply to a Variety of Bleeding Sites. | Neutral | 46 Participants |
Other Pre-specified
This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation.
This product is easy to cut to size for application on various sized bleeding sites e.g., a customized preparation.
Time frame: Intraoperative
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| EVARREST Fibrin Sealant Patch | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Strongly Disagree | 1 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Disagree | 0 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Neutral | 0 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Agree | 7 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Strongly Agree | 66 Participants |
| EVARREST Fibrin Sealant Patch | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Not applicable | 1 Participants |
| Standard of Care (SoC) | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Strongly Agree | 15 Participants |
| Standard of Care (SoC) | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Strongly Disagree | 5 Participants |
| Standard of Care (SoC) | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Agree | 8 Participants |
| Standard of Care (SoC) | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Disagree | 0 Participants |
| Standard of Care (SoC) | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Not applicable | 2 Participants |
| Standard of Care (SoC) | This Product is Easy to Cut to Size for Application on Various Sized Bleeding Sites e.g., a Customized Preparation. | Neutral | 45 Participants |