Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.

Detailed Description
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A maximum of 104 subjects will be enrolled across a maximum of 5 study sites in the United States. The estimated duration of the study is approximately 8 months from the time of first subject enrollment to the last subject enrollment. Enrollment occurs intraoperatively after confirmation of the intraoperative eligibility criteria. Subjects will undergo intraoperative performance assessments and then will be discontinued from the study after completion of the intraoperative visit.

Official Title
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Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

Conditions
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Cardiothoracic Surgery

Intervention / Treatment
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* Device: HEMOBLAST Bellows
* Device: FLOSEAL


Participation Criteria
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Eligibility Criteria
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Preoperative Inclusion Criteria Subject is undergoing a non-emergent cardiothoracic surgery; and Subject or an authorized legal representative is willing and able to give prior written informed consent for study participation. Preoperative Exclusion Criteria 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 religious or other objections to porcine or bovine components; and Subject is not appropriate for inclusion in the clinical study, per the medical opinion of the Investigator. Intraoperative Inclusion Criteria 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 hemostasis are ineffective or impractical; and Subject has a TBS with minimal, mild, or moderate bleeding
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: HEMOBLAST Bellows (Hemostatic Device)<br>Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use | Device: HEMOBLAST Bellows<br>* The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.<br>|
| Active Comparator: FLOSEAL (Hemostatic Device)<br>Bleeding sites will be treated with FLOSEAL per its approved Indications for Use | Device: FLOSEAL<br>* The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or 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 |
| --- | --- | --- |
| 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes | The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes | The secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes. | Intraoperative |