Evaluation of Safety of HEMOBLAST Bellows in Spine Surgery

Study Overview
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Brief Summary
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The purpose of this clinical investigation in open, elective, spine surgery is to collect data to support the removal of the neurosurgical exclusion from the currently approved indication for the use of HEMOBLAST™ Bellows. This study is primarily designed to assess safety of the device for use in spine surgery, although efficacy information will also be captured and reported.

Official Title
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Prospective, Randomized, Controlled, Multicenter, Clinical Investigation Evaluating the Safety of HEMOBLAST™ Bellows in Spine Surgery

Conditions
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Surgical Bleeding

Intervention / Treatment
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* Device: HEMOBLAST™ Bellows
* Device: absorbable gelatin sponge with thrombin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is undergoing open, elective, spine surgery Subject or an authorized legal representative is willing and able to give prior written informed consent for investigation participation Subject is 22 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 hemostasis are ineffective or impractical Subject has a TBS with a Surface Bleeding Severity Scale (SBSS) score of 1, 2, or 3 Exclusion Criteria: Subject is undergoing an emergency surgical procedure Subject is undergoing a laparoscopic surgery Subject is undergoing a cervical spine surgery Subject is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding Subject has 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 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 a known sensitivity or allergy to Gadolinium The subject has a contra-indication for MRI or gadolinium contrast agent according to clinical guidelines, local regulations or manufacturer's recommendations Subject suffers from claustrophobia or fear of MRI, or has any contraindication to MRI (e.g., metal implants, spinal cord stimulator, etc. not suited to MRI) Subject has American Society of Anesthesiologists classification of > 4 Subject has a life expectancy of less than 3 months Subject has a documented severe congenital or acquired immunodeficiency Subject has religious or other objections to porcine, bovine, or human components 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 Per investigator opinion subject is unable to fully cooperate with the study protocol. The product will be placed in at the site where the dura is open The product will be placed in the intradural or cranial space

Ages Eligible for Study
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Minimum Age: 22 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
Interventional Model Description: Prospective, Randomized, Controlled, Multicenter, Clinical Investigation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: investigational<br>HEMOBLAST™ Bellows | Device: HEMOBLAST™ Bellows<br>* Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows<br>|
| Active Comparator: control<br>absorbable gelatin sponge with thrombin | Device: absorbable gelatin sponge with thrombin<br>* Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Unanticipated Adverse Device Effect (UADE) | incidence of UADE, for subjects treated with HEMOBLAST™, as determined by the Independent Data Monitoring Committee (IDMC). | 3 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (AE) | the proportion of AEs for subjects treated with HEMOBLAST™ compared to subjects treated with G+T. | 3 months follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Elective, spine surgery, bleeding control, hemostasis