HEMOBLAST Pivotal Clinical Investigation

Study Overview
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Brief Summary
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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.

Official Title
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Prospective, Randomized, Controlled, Multicenter, Pivotal, Clinical Investigation Evaluating the Safety and Efficacy of HEMOBLAST Bellows in Cardiothoracic, Abdominal, and Orthopedic Lower Extremity Surgeries

Conditions
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Hemostasis

Intervention / Treatment
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* Device: HEMOBLAST Bellows
* Device: Absorbable gelatin sponge, USP with thrombin


Participation Criteria
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Eligibility Criteria
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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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational<br>HEMOBLAST Bellows | Device: HEMOBLAST Bellows<br> <br> |
| Active Comparator: Control<br>Absorbable gelatin sponge, USP with thrombin | Device: Absorbable gelatin sponge, USP with thrombin<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Intraoperative, 6 Minutes Post-Application | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Product Preparation Time | The average time from the opening of the package to the product being ready to use, measured in minutes and seconds. | Intraoperative | 
| Proportion of Subjects Achieving Hemostasis | The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated | Intraoperative, 3 Minutes Post-Application |