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

NACompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

March 1, 2019

Primary Completion Date

June 28, 2019

Study Completion Date

June 28, 2019

Conditions
Cardiothoracic Surgery
Interventions
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.

DEVICE

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.

Trial Locations (4)

70124

Ochsner Clinic Foundation, New Orleans

77030

Houston Methodist, Houston

90095

University of California Los Angeles, Los Angeles

96819

Kaiser Permanente Moanalua Medical Center, Honolulu

All Listed Sponsors
lead

Biom'Up France SAS

INDUSTRY

NCT03725098 - Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations | Biotech Hunter | Biotech Hunter