N/A N=258 Randomized Single-blind Treatment

HEMOBLAST Pivotal Clinical Investigation

Hemostasis

Bottom Line

View on ClinicalTrials.gov: NCT02780869 ↗

Enrolled (actual)

258

Serious AEs

11.6%

Results posted

Nov 2018

Primary outcome: Primary: Proportion of Subjects Achieving Hemostasis — 148; 61 Participants — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: HEMOBLAST Bellows (Device); Absorbable gelatin sponge, USP with thrombin (Device)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Biom'Up France SAS
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Subjects Achieving Hemostasis	113; 38	<0.0001 sig
SECONDARY Product Preparation Time	0.37; 2.40	<0.0001 sig
SECONDARY Proportion of Subjects Achieving Hemostasis	113; 38	<0.0001 sig

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.

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02780869). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.