Cardiothoracic Surgery
Conditions
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.
Interventions
DEVICEHEMOBLAST 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.
DEVICEFLOSEAL
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.
Sponsors
Biom'Up France SAS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes | 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. |
Countries
United States
Participant flow
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 53 |
| 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. | 52 |
| Total | 105 |
Baseline characteristics
| Characteristic | FLOSEAL (Hemostatic Device) | Total | HEMOBLAST Bellows (Hemostatic Device) |
|---|---|---|---|
| Age, Continuous | 64.9 years STANDARD_DEVIATION 12.1 | 63.7 years STANDARD_DEVIATION 11.7 | 62.6 years STANDARD_DEVIATION 11.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 10 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 94 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 15 Participants | 24 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 10 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 6 Participants | 13 Participants | 7 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 9 Participants | 6 Participants |
| Race (NIH/OMB) White | 22 Participants | 49 Participants | 27 Participants |
| Sex: Female, Male Female | 8 Participants | 24 Participants | 16 Participants |
| Sex: Female, Male Male | 44 Participants | 81 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 53 | 0 / 52 |
| other Total, other adverse events | 0 / 53 | 0 / 52 |
| serious Total, serious adverse events | 0 / 53 | 0 / 52 |
Outcome results
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.
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEMOBLAST Bellows (Hemostatic Device) | 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes | 34 Participants |
| FLOSEAL (Hemostatic Device) | 3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes | 5 Participants |
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.
Time frame: Intraoperative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HEMOBLAST Bellows (Hemostatic Device) | 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes | 49 Participants |
| FLOSEAL (Hemostatic Device) | 5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes | 23 Participants |