Trial Outcomes & Findings for HEMOBLAST Pivotal Clinical Investigation (NCT NCT02780869)

Last Updated: 2018-12-27

Results Overview

The proportion of subjects achieving hemostasis at 6 minutes post-hemostat application was calculated. Hemostasis was defined as a grade of 0 (None/Dry) on the Surface Bleeding Severity Scale, with additional grades, ranging from 1 (Minimal/Oozing) to 5 (Extreme/Gushing), considered a failure of hemostasis.

Recruitment status

COMPLETED

Study phase

Target enrollment

258 participants

Primary outcome timeframe

Intraoperative, 6 Minutes Post-Application

Results posted on

2018-12-27

Participant Flow

First subject completed follow-up: August 19, 2016 Last patient completed follow-up: January 18, 2017

Subject enrollment occurred after the subject met preoperative eligibility criteria, gave written informed consent, and met intraoperative eligibility criteria. Subjects were randomized and treated subsequent to enrollment. Subjects could withdraw or be withdrawn from the study at any time after enrollment, including prior to treatment.

Participant milestones

Participant milestones
Measure	Investigational HEMOBLAST Bellows HEMOBLAST Bellows	Control Absorbable gelatin sponge, USP with thrombin Absorbable gelatin sponge, USP with thrombin
Overall Study STARTED	175	83
Overall Study COMPLETED	162	74
Overall Study NOT COMPLETED	13	9

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HEMOBLAST Pivotal Clinical Investigation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational n=175 Participants HEMOBLAST Bellows	Control n=83 Participants Absorbable gelatin sponge, USP with thrombin	Total n=258 Participants Total of all reporting groups
Age, Continuous	56.9 years STANDARD_DEVIATION 14.79 • n=5 Participants	56.2 years STANDARD_DEVIATION 14.62 • n=7 Participants	56.7 years STANDARD_DEVIATION 14.71 • n=5 Participants
Sex: Female, Male Female	106 Participants n=5 Participants	49 Participants n=7 Participants	155 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants	34 Participants n=7 Participants	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	7 Participants n=7 Participants	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	157 Participants n=5 Participants	76 Participants n=7 Participants	233 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	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) Black or African American	25 Participants n=5 Participants	14 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) White	123 Participants n=5 Participants	57 Participants n=7 Participants	180 Participants n=5 Participants
Race (NIH/OMB) More than one race	11 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative, 6 Minutes Post-Application

Population: The efficacy analysis population was defined as the Time-To-Hemostasis (TTH) population and included all subjects who were randomized, received study intervention, and had a TTH assessment recorded.

Outcome measures

Outcome measures
Measure	Investigational n=159 Participants HEMOBLAST Bellows	Control n=83 Participants Absorbable gelatin sponge, USP with thrombin
Proportion of Subjects Achieving Hemostasis	148 Participants	61 Participants

SECONDARY outcome

Timeframe: Intraoperative

The average time from the opening of the package to the product being ready to use, measured in minutes and seconds.

Outcome measures

Outcome measures
Measure	Investigational n=159 Participants HEMOBLAST Bellows	Control n=83 Participants Absorbable gelatin sponge, USP with thrombin
Product Preparation Time	0.37 Minutes Standard Deviation 0.16	2.40 Minutes Standard Deviation 0.794

SECONDARY outcome

Timeframe: Intraoperative, 3 Minutes Post-Application

The proportion of subjects achieving hemostasis at 3 minutes post-hemostat application was calculated

Outcome measures

Outcome measures
Measure	Investigational n=159 Participants HEMOBLAST Bellows	Control n=83 Participants Absorbable gelatin sponge, USP with thrombin
Proportion of Subjects Achieving Hemostasis	113 Participants	38 Participants

Adverse Events

Investigational

Serious events: 19 serious events

Other events: 84 other events

Deaths: 0 deaths

Control

Serious events: 11 serious events

Other events: 47 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Investigational n=175 participants at risk HEMOBLAST Bellows	Control n=83 participants at risk Absorbable gelatin sponge, USP with thrombin
Blood and lymphatic system disorders Abnormal bloodwork	7.4% 13/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	6.0% 5/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
Blood and lymphatic system disorders Anemia	5.7% 10/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	10.8% 9/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
Gastrointestinal disorders Constipation/ileus	6.9% 12/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	6.0% 5/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
Cardiac disorders Arrythmia	9.1% 16/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	8.4% 7/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
General disorders Fluid overload	4.6% 8/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	6.0% 5/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
Infections and infestations Infection	4.0% 7/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	7.2% 6/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
General disorders Nausea	8.6% 15/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	3.6% 3/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
General disorders Pain	14.3% 25/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	13.3% 11/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'
Skin and subcutaneous tissue disorders Wound related	6.9% 12/175 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'	4.8% 4/83 • Enrollment until completion of 6-week follow-up visit All adverse events (AEs) through final follow-up were collected. An AE is defined according to the European Standard EN ISO 14155 as 'any untoward medical occurrence in a subject.' An AE related to a device (adverse device effect, ADE) is defined as 'any untoward and unintended response to an investigational medical device.'

Additional Information

Rachel Hoffman, Vice President Clinical Operations North America

Biom'up

Phone: 404-702-9253

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60