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

Biom'Up France SAS105 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

105

Conditions

Cardiothoracic Surgery

Interventions

HEMOBLAST BellowsDEVICE

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.

FLOSEALDEVICE

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.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (4)

University of California Los Angeles

Los Angeles, California, United States

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Houston Methodist

Houston, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative

Secondary Outcomes

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.

Time frame: Intraoperative

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.