HEMOBLAST Pivotal Clinical Investigation

• HEMOBLAST Bellows (Device)
• Absorbable gelatin sponge, USP with thrombin (Device)

Primary outcomes

• 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 outcomes

• 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

Sex: All, ages: 21 Years to any

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.

Participant flow

Outcome results

• Proportion of Subjects Achieving Hemostasis (Primary), Count of participants, Participants: Investigational 148; Control 61 (p <0.0001)
• Product Preparation Time (Secondary), Mean, Minutes: Investigational 0.37 +/- 0.16; Control 2.40 +/- 0.794 (p <0.0001)
• Proportion of Subjects Achieving Hemostasis (Secondary), Count of participants, Participants: Investigational 113; Control 38 (p <0.0001)

Adverse events

Time frame: Enrollment until completion of 6-week follow-up visit

Serious adverse events by term

Other adverse events by term

• Study Protocol (PDF, 2016-06-20)
• Statistical Analysis Plan (PDF, 2016-07-01)

• William Chapman, MD, Principal investigator, Washington University School of Medicine