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The purpose of this study is to evaluate the performance of HEMOBLAST™ compared to FLOSEAL in cardiothoracic operations.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEMOBLAST Bellows (Hemostatic Device) | Experimental | Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use |
|
| FLOSEAL (Hemostatic Device) | Active Comparator | Bleeding sites will be treated with FLOSEAL per its approved Indications for Use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HEMOBLAST Bellows | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Preoperative Inclusion Criteria
Preoperative Exclusion Criteria
Intraoperative Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Brian Bruckner, MD | The Methodist Hospital Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Los Angeles | Los Angeles | California | 90095 | United States | ||
| Kaiser Permanente Moanalua Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31763732 | Background | 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. |
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One additional subject was enrolled due to a delay in the reporting function of the electronic database used for the study. This additional subject is not anticipated to affect the analyses or ethical conduct of the study, as all subjects were treated on-label for an approved device in this post-market study
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| ID | Title | Description |
|---|---|---|
| FG000 | HEMOBLAST Bellows (Hemostatic Device) | Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use 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. |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 15, 2018 |
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| FLOSEAL | Device | 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. |
|
| Honolulu |
| Hawaii |
| 96819 |
| United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70124 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| FG001 | FLOSEAL (Hemostatic Device) | Bleeding sites will be treated with FLOSEAL per its approved Indications for Use 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. |
|
| COMPLETED |
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| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HEMOBLAST Bellows (Hemostatic Device) | Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use 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. |
| BG001 | FLOSEAL (Hemostatic Device) | Bleeding sites will be treated with FLOSEAL per its approved Indications for Use 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | Intraoperative |
|
Enrollment to discontinuation (intraoperative period, approximately 8 hours))
The rate of occurrence of device malfunctions, device-related adverse events (AEs), serious adverse device effects (SADEs), and unanticipated adverse device effects (UADEs) were summarized for each treatment group by severity.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HEMOBLAST Bellows (Hemostatic Device) | Bleeding sites will be treated with HEMOBLAST Bellows per its approved Indications for Use 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. | 0 | 53 | 0 | 53 | 0 | 53 |
| EG001 | FLOSEAL (Hemostatic Device) | Bleeding sites will be treated with FLOSEAL per its approved Indications for Use 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. | 0 | 52 | 0 | 52 | 0 | 52 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| William Spotnitz, MD, MBA | Biom'up | 351-514-5009 | w.spotnitz@biomup.com |
| Dec 19, 2019 |
| Prot_SAP_000.pdf |
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
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| Units | Counts |
|---|---|
| Participants |
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