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

Biom'Up France SAS17 sites in 1 country258 target enrollmentJuly 18, 2016

ConditionsHemostasis

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hemostasis
Sponsor: Biom'Up France SAS
Enrollment: 258
Locations: 17
Primary Endpoint: Proportion of Subjects Achieving Hemostasis
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

July 18, 2016

End Date

March 27, 2017

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Biom'Up France SAS

Responsible Party

Sponsor

Eligibility Criteria

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;

Outcomes

Primary Outcomes

Proportion of Subjects Achieving Hemostasis

Time Frame: 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.