Hemostasis
Conditions
Brief summary
The purpose of this prospective, randomized, controlled study is to evaluate the safety and efficacy of a new hemostatic device (HEMOBLAST™ Bellows) compared to a control device, absorbable gelatin sponge USP with thrombin.
Interventions
DEVICEHEMOBLAST Bellows
DEVICEAbsorbable gelatin sponge, USP with thrombin
Sponsors
Biom'Up France SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* • Subject is undergoing an elective open cardiothoracic, abdominal, or orthopedic lower extremity surgery; * Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation; * Subject undergoing cardiothoracic surgery is not allergic to protamine; and * Subject is 21 years of age or older.
Exclusion criteria
* • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure; * Subject is undergoing a neurologic surgical procedure; * Subject is undergoing a spinal surgical procedure; * Subject is undergoing an emergency surgical procedure; * Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding; * Subject has a clinically significant coagulation disorder or disease, defined as a platelet count \< 100,000 per microliter or International Normalized Ratio \> 1.5 within 4 weeks of surgery; * Subject receiving intravenous heparin within 12 hours before surgery or oral Coumadin within 2 days before surgery; * Subject receiving antiplatelet medications within 5 days prior to surgery; * Subject undergoing abdominal or orthopedic lower extremity surgery receiving aspirin within 7 days prior to surgery; * Subject has an active or suspected infection at the surgical site; * Subject has had or has planned to receive any organ transplantation; * Subject has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent; * Subject has ASA classification of 5; * Subject has a life expectancy of less than 3 months; * Subject has a known psychiatric disorder, which in the opinion of the Principal Investigator, would preclude the subject from completing this clinical study; * Subject has a documented severe congenital or acquired immunodeficiency; * Subject has religious or other objections to porcine, bovine, or human components; * Subject in whom the investigational or control device will be used at the site of a valve replacement or repair; * Subject in whom the investigational or control device will be used at the site of a synthetic graft or patch implant; * Subject is currently participating or has participated in another clinical trial within the past 30 days and is receiving/has received an investigational drug, device, or biologic agent; and * Subject is not appropriate for inclusion in the clinical trial, per the medical opinion of the Principal Investigator. Intraoperative Eligibility Criteria: * Subject does not have an active or suspected infection at the surgical site; * Subject undergoing cardiothoracic surgery with anticoagulation must have anticoagulation reversed prior to target bleeding site (TBS) identification and treatment; * Subject in whom the Investigator is able to identify a TBS for which any applicable conventional means for hemostasis are ineffective or impractical; and * Subject has a TBS with an SBSS score of 1, 2, or 3.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects Achieving Hemostasis | Intraoperative, 6 Minutes Post-Application | The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Product Preparation Time | Intraoperative | The average time from the opening of the package to the product being ready to use, measured in minutes and seconds. |
| Proportion of Subjects Achieving Hemostasis | Intraoperative, 3 Minutes Post-Application | The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated |
Countries
United States
Participant flow
Recruitment details
First subject completed follow-up: August 19, 2016 Last patient completed follow-up: January 18, 2017
Pre-assignment details
Subject enrollment occurred after the subject met preoperative eligibility criteria, gave written informed consent, and met intraoperative eligibility criteria. Subjects were randomized and treated subsequent to enrollment. Subjects could withdraw or be withdrawn from the study at any time after enrollment, including prior to treatment.
Participants by arm
| Arm | Count |
|---|---|
| Investigational HEMOBLAST Bellows | 175 |
| Control Absorbable gelatin sponge, USP with thrombin | 83 |
| Total | 258 |
Baseline characteristics
| Characteristic | Control | Total | Investigational |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 14.62 | 56.7 years STANDARD_DEVIATION 14.71 | 56.9 years STANDARD_DEVIATION 14.79 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 24 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 76 Participants | 233 Participants | 157 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 12 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 39 Participants | 25 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 15 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 57 Participants | 180 Participants | 123 Participants |
| Sex: Female, Male Female | 49 Participants | 155 Participants | 106 Participants |
| Sex: Female, Male Male | 34 Participants | 103 Participants | 69 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 175 | 3 / 83 |
| other Total, other adverse events | 84 / 175 | 47 / 83 |
| serious Total, serious adverse events | 19 / 175 | 11 / 83 |
Outcome results
Primary
Proportion of Subjects Achieving Hemostasis
The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.
Time frame: Intraoperative, 6 Minutes Post-Application
Population: The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational | Proportion of Subjects Achieving Hemostasis | 148 Participants |
| Control | Proportion of Subjects Achieving Hemostasis | 61 Participants |
p-value: <0.0001Cochran-Mantel-Haenszel
Comparison: A secondary endpoint of superiority of HEMOBLAST relative to G+T for success at achieving hemostasis within 6 minutes was evaluated.p-value: 0.0001Cochran-Mantel-Haenszel
Secondary
Product Preparation Time
The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.
Time frame: Intraoperative
Population: The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational | Product Preparation Time | 0.37 Minutes | Standard Deviation 0.16 |
| Control | Product Preparation Time | 2.40 Minutes | Standard Deviation 0.794 |
Comparison: The difference in mean preparation time was tested using a linear regression model with stratified adjustment for surgery type.p-value: <0.0001Regression, Linear
Secondary
Proportion of Subjects Achieving Hemostasis
The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated
Time frame: Intraoperative, 3 Minutes Post-Application
Population: The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Investigational | Proportion of Subjects Achieving Hemostasis | 113 Participants |
| Control | Proportion of Subjects Achieving Hemostasis | 38 Participants |
p-value: <0.0001Regression, Logistic
p-value: 0.0001Regression, Logistic