Clinical trial NCT03725098: Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
Official title: Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiothoracic Surgery
Lead sponsor: Biom'Up France SAS
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 105
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes
timeFrame: Intraoperative
Secondary outcomes:
measure: 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Honolulu
country: United States
facility: Kaiser Permanente Moanalua Medical Center
state: Hawaii
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Brian Bruckner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2020 Feb;35(2):313-319. doi: 10.1111/jocs.14376. Epub 2019 Nov 25.