Trial Outcomes & Findings for Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations (NCT NCT03725098)
NCT ID: NCT03725098
Last Updated: 2020-01-13
Results Overview
The primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
105 participants
Primary outcome timeframe
Intraoperative
Results posted on
2020-01-13
Participant Flow
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
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
53
|
52
|
|
Overall Study
COMPLETED
|
53
|
52
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study Evaluating the Performance of HEMOBLAST Bellows Compared to FLOSEAL Hemostatic Matrix in Cardiothoracic Operations
Baseline characteristics by cohort
| Measure |
HEMOBLAST Bellows (Hemostatic Device)
n=53 Participants
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.
|
FLOSEAL (Hemostatic Device)
n=52 Participants
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.
|
Total
n=105 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
64.9 years
STANDARD_DEVIATION 12.1 • n=7 Participants
|
63.7 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
44 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: IntraoperativeThe primary endpoint of this study is the superiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 3 minutes.
Outcome measures
| Measure |
HEMOBLAST Bellows (Hemostatic Device)
n=53 Participants
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.
|
FLOSEAL (Hemostatic Device)
n=52 Participants
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.
|
|---|---|---|
|
3 Minute Hemostasis - Hemostatic Success (Yes/no) at 3 Minutes
|
34 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: IntraoperativeThe secondary endpoint of this study is non-inferiority of HEMOBLAST™ relative to FLOSEAL for the proportion of subjects reaching hemostasis within 5 minutes.
Outcome measures
| Measure |
HEMOBLAST Bellows (Hemostatic Device)
n=53 Participants
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.
|
FLOSEAL (Hemostatic Device)
n=52 Participants
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.
|
|---|---|---|
|
5 Minute Hemostasis - Hemostatic Success (Yes/no) at 5 Minutes
|
49 Participants
|
23 Participants
|
Adverse Events
HEMOBLAST Bellows (Hemostatic Device)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FLOSEAL (Hemostatic Device)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place