A Premarket, Prospective, Randomized, Single-Blind Study... | NCT01639833

Status Module

Label	Type	Description	Intervention Names
Veriset Hemostatic Patch	Experimental	Topical Hemostat	Device: Veriset Hemostatic Patch
TachoSil®	Active Comparator	Topical Hemostat	Device: TachoSil®

Name	Type	Description	Arm Group Labels	Other Names
Veriset Hemostatic Patch	Device	Topical hemostat	Veriset Hemostatic Patch

Measure	Description	Time Frame
Time to Hemostasis (TTH)	Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).	Day 0

Measure	Description	Time Frame
Hemostasis at All Treated Bleeding Sites Within 3 Minutes	The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.	Day 0

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject has provided informed consent.
Subject is ≥18 years of age.
Subject is scheduled for surgery involving the aorta (e.g., aortic valve replacement (AVR), David procedure, Bentall procedure, abdominal aortic aneurysm repair, etc.), or coronary artery bypass graft (CABG) where a topical hemostatic agent would be used to control bleeding via an open approach.
Subject is willing and able to comply with all aspects of the treatment and evaluation schedule.
Subject is undergoing emergency surgery, i.e. lifesaving procedures performed where patient is in imminent danger of death.
Subject has a history of allergic reactions after application of human fibrinogen, human thrombin and/or collagen of any origin.
Subject is pregnant (documented by a positive pregnancy test) or is actively breast-feeding.
Subject has an estimated life expectancy of less than 6 months.
Subject is unwilling to receive blood products.
Subject is scheduled for another planned cardiovascular surgery, and subsequent surgery would jeopardize previous application of study treatment.
The subject has participated in another investigational drug or device research study within 30 days of enrollment.

Exclusion Criteria:

Subject has an appropriate Target Bleeding Site (TBS) defined as an area of bleeding on the aorta or coronary vessels where hemostasis by conventional methods is ineffective or impractical, and thus necessitates the use of a topical hemostatic agent.
TBS Bleeding is Type 2 (Oozing/Mild) or 3 (Moderate).
It is possible to hold pressure on Veriset™ Hemostatic Patch or TachoSil® for at least 3 minutes.
Incidental finding of any other pre-operative exclusion criteria
Subject does not have an appropriate TBS.
TBS Bleeding Assessment is Type 1 (No bleeding) or 4 (Severe/Surgical/Life Threatening).
Subject has an active local infection at the surgical site.
Investigator determines that participation in the study may jeopardize the safety or welfare of the subject.

Name	Affiliation	Role
David Glineur, MD	Clinique St-Luc Bouge, Namur, Belgium	Principal Investigator

Results Section

Participant Flow Module

ID	Title	Description
FG000	Veriset™ Hemostatic Patch	Topical Hemostat Veriset™ Hemostatic Patch: Topical hemostat
FG001	TachoSil®	Topical Hemostat TachoSil®: Topical Hemostat

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

ID	Title	Description
BG000	Veriset™ Hemostatic Patch	Topical Hemostat Veriset™ Hemostatic Patch: Topical hemostat
BG001	TachoSil®	Topical Hemostat TachoSil®: Topical Hemostat
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG00045 BG00145 BG00290

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00068.5± 12.2 BG00166.7± 13.4 BG00267.6± 12.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00016 BG00113 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0001 BG0010 BG002

Height

Mean

Standard Deviation

centimeters

Title

Denominators

Categories

Title	Measurements
	BG000171.3± 9.1 BG001170.8± 10.4 BG002

Weight

Mean

Standard Deviation

kilograms

Title

Denominators

Categories

Title	Measurements
	BG00081.67± 14.27 BG00181.96± 17.27 BG002

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

Time to Hemostasis (TTH)

Time to Hemostasis (TTH) at the target bleeding site (TBS) following treatment (Veriset™ Hemostatic Patch or Control).

The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.

Posted

Median

95% Confidence Interval

minutes

Day 0

ID	Title	Description
OG000	Veriset™ Hemostatic Patch	Topical Hemostat Veriset™ Hemostatic Patch: Topical hemostat
OG001	TachoSil®	Topical Hemostat TachoSil®: Topical Hemostat

Units	Counts
Participants	OG00041 OG00145

Title

Denominators

Categories

Title	Measurements
	OG0001.50(1.50 to 2.00) OG0013.00(NA to NA)Confidence interval was calculated using the Brookmeyer and Crowley method. 91% of TachoSil® patients achieved hemostasis at 3 minutes and no patient had hemostasis before 3 minutes. The confidence interval of the median time cannot be estimated.

Secondary

Hemostasis at All Treated Bleeding Sites Within 3 Minutes

The proportion of subjects achieving hemostasis at all treated bleeding sites within 3 minutes of device application.

The Per Protocol (PP) population was used for the primary analysis of the primary effectiveness endpoint for the non-inferiority test.

Posted

Number

95% Confidence Interval

percentage of participants

Day 0

ID	Title	Description
OG000	Veriset™ Hemostatic Patch	Topical Hemostat Veriset™ Hemostatic Patch: Topical hemostat
OG001	TachoSil®	Topical Hemostat TachoSil®: Topical Hemostat

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Bradycardia	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Cardiac arrest	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected44 at risk EG0010 affected45 at risk
Low cardiac output syndrome	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Sick sinus syndrome	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Trifascicular block	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Ventricular failure	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Death	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Impaired healing	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Multi-organ failure	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Diverticulitis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Endocarditis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Pneumonia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Pneumonia escherichia	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Postoperative wound infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Vascular graft complication	Injury, poisoning and procedural complications	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Cardiac output decreased	Investigations	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Hemianopia	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Hemiparesis	Nervous system disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Haematuria	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0011 affected45 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Lung disorder	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected44 at risk EG0011 affected45 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0002 affected44 at risk EG0010 affected45 at risk
Haemorrhage	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0001 affected44 at risk EG0010 affected45 at risk
Thrombosis	Vascular disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0011 affected45 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0005 affected44 at risk EG0010 affected45 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG00013 affected44 at risk EG00110 affected45 at risk
Urinary tract infection	Infections and infestations	MedDRA 14.1	Non-systematic Assessment	EG0003 affected44 at risk EG0010 affected45 at risk
Delirium	Psychiatric disorders	MedDRA 14.1	Non-systematic Assessment	EG0003 affected44 at risk EG0010 affected45 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG0006 affected44 at risk EG0017 affected45 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.1	Non-systematic Assessment	EG00012 affected44 at risk EG00113 affected45 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0014 affected45 at risk
Pericardial effusion	Cardiac disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0014 affected45 at risk
Renal failure	Renal and urinary disorders	MedDRA 14.1	Non-systematic Assessment	EG0000 affected44 at risk EG0014 affected45 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Bonheiden			Belgium
St Luc Hospital

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Veriset™ Hemostatic Patch	Topical Hemostat Veriset™ Hemostatic Patch: Topical hemostat			13	44	23	44
EG001	TachoSil®	Topical Hemostat TachoSil®: Topical Hemostat			11	45	21	45