HEMOBLAST Pilot Clinical Investigation

Study Overview
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Brief Summary
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The primary objective of this pilot clinical investigation is to assess the reliability of the Surface Bleeding Severity Scale (SBSS) in a clinical setting. Secondary objectives of this clinical investigation are to collect initial data on the safety and efficacy of HEMOBLAST™ Bellows in abdominal and orthopedic lower extremity surgeries.

Detailed Description
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HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical. This is a prospective, multicenter, single-arm pilot clinical investigation. There will be 36 subjects enrolled across 4 investigational sites. The subjects will be followed at hospital charge and 6 weeks postoperatively. The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators. Secondary endpoints of this clinical investigation consist of: Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application; Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application; Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application; and Incidence of adverse events through final follow-up.

Official Title
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Prospective, Multicenter, Single-arm Pilot Clinical Investigation Evaluating the Use of a Surface Bleeding Severity Scale (SBSS) and the Safety and Efficacy of a New Hemostatic Device in Abdominal and Orthopedic Lower Extremity Surgeries

Conditions
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Hemostasis

Intervention / Treatment
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* Device: HEMOBLAST Bellows


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Subject is undergoing an elective open 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; Subjects on antiplatelets, including aspirin, will discontinue medication at least 10 days prior to surgery; and Subject is 21 years of age or older. Subject does not have an active or suspected infection at the surgical site; Subject in whom the Investigator is able to identify a target bleeding site (TBS) for which any applicable conventional means for achieving hemostasis are ineffective or impractical; and Subject has a TBS with an SBSS score of 1, 2, or 3. Exclusion Criteria: • Subject is undergoing a laparoscopic, thoracoscopic, or robotic surgical procedure; Subject is undergoing a spinal surgical procedure; Subject is undergoing a neurologic 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 and/or International Normalized Ratio > 1.5 within 4 weeks of surgery; Subject had chronic corticosteroid use within 2 weeks prior to surgery; Subject receiving intravenous heparin or oral Coumadin within 24 hours of surgery; Subject has an active or suspected infection at the surgical site; Subject has had or has planned 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 > 4; 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 or bovine components; Subject in whom the investigational device will be used at the site of a cemented or uncemented porous coated joint 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HEMOBLAST<br>All subjects will have the investigational device implanted | Device: HEMOBLAST Bellows<br>* HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Paired Kappa Statistic for the Assignment of SBSS Scores by 2 Investigators | The primary endpoint of this clinical investigation is the mean paired Kappa statistic for the assignment of SBSS scores by 2 Investigators. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostatic Within 6 Minutes | Proportion of subjects achieving hemostasis within 6 minutes of HEMOBLAST™ Bellows application | Intraoperative | 
| Hemostasis Within 10 Minutes | Proportion of subjects achieving hemostasis within 10 minutes of HEMOBLAST™ Bellows application | Intraoperative | 
| Hemostasis Within 3 Minutes | Proportion of subjects achieving hemostasis within 3 minutes of HEMOBLAST™ Bellows application | Intraoperative | 
| Adverse Events | Incidence of adverse events through final follow-up | 6 +/- 2 weeks after implant |