NCT03725098

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 30, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

January 13, 2020

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

October 8, 2018

Results QC Date

December 19, 2019

Last Update Submit

January 7, 2020

Conditions

Cardiothoracic Surgery

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes

    Intraoperative

Study Arms (2)

HEMOBLAST Bellows (Hemostatic Device)

EXPERIMENTAL

Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use

Device: HEMOBLAST Bellows

FLOSEAL (Hemostatic Device)

ACTIVE COMPARATOR

Bleeding sites will be treated with FLOSEAL per its approved Indications for Use

Device: FLOSEAL

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.

HEMOBLAST Bellows (Hemostatic Device)
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.

FLOSEAL (Hemostatic Device)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

Kaiser Permanente Moanalua Medical Center

Honolulu, Hawaii, 96819, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70124, United States

Location

Houston Methodist

Houston, Texas, 77030, United States

Location

Related 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. 2020 Feb;35(2):313-319. doi: 10.1111/jocs.14376. Epub 2019 Nov 25.

    PMID: 31763732BACKGROUND

Results Point of Contact

Title
William Spotnitz, MD, MBA
Organization
Biom'up
w.spotnitz@biomup.com
351-514-5009

Study Officials

  • Brian Bruckner, MD

    The Methodist Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2018

First Posted

October 30, 2018

Study Start

March 1, 2019

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

January 13, 2020

Results First Posted

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(4)