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

Cardiothoracic Surgery Clinical Trial

Official title:

Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03725098
• Other study ID #: ETC 2018-005
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: June 28, 2019

Study information

• Verified date: January 2020
• Source: Biom'Up SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: June 28, 2019
• Est. primary completion date: June 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiothoracic Surgery

Intervention

Device:
• HEMOBLAST Bellows
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.
• FLOSEAL
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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Moanalua Medical Center	Honolulu	Hawaii
United States	Houston Methodist	Houston	Texas
United States	University of California Los Angeles	Los Angeles	California
United States	Ochsner Clinic Foundation	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Biom'Up SA

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dang NC, Ardehali A, Bruckner BA, Parrino PE, Gillen DL, Hoffman RW, Spotnitz R, Cavoores S, Shorn IJ, Manson RJ, Spotnitz WD. Prospective, multicenter, randomized, controlled trial evaluating the performance of a novel combination powder vs hemostatic matrix in cardiothoracic operations. J Card Surg. 2019 Nov 25. doi: 10.1111/jocs.14376. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Intraoperative
Secondary	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.	Intraoperative