Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
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|ClinicalTrials.gov Identifier: NCT03725098|
Recruitment Status : Completed
First Posted : October 30, 2018
Results First Posted : January 13, 2020
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cardiothoracic Surgery||Device: HEMOBLAST Bellows Device: FLOSEAL||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective, Randomized, Controlled, Multicenter, Post-Market Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||June 28, 2019|
|Actual Study Completion Date :||June 28, 2019|
Experimental: HEMOBLAST Bellows (Hemostatic Device)
Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use
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.
Active Comparator: FLOSEAL (Hemostatic Device)
Bleeding sites will be treated with FLOSEAL per its approved Indications for Use
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.
- 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes [ Time Frame: Intraoperative ]The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.
- 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes [ Time Frame: Intraoperative ]The secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725098
|United States, California|
|University of California Los Angeles|
|Los Angeles, California, United States, 90095|
|United States, Hawaii|
|Kaiser Permanente Moanalua Medical Center|
|Honolulu, Hawaii, United States, 96819|
|United States, Louisiana|
|Ochsner Clinic Foundation|
|New Orleans, Louisiana, United States, 70124|
|United States, Texas|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Brian Bruckner, MD||Houston Methodist|