Trial Outcomes & Findings for Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery (NCT NCT01324349)

Last Updated: 2014-03-03

Results Overview

Stopwatches will be provided to document time to hemostasis. Hemostasis will be assessed every 30 seconds until the 5-minute time point, at which point the visual inspection will continue at one-minute intervals up to 10 minutes or until hemostasis is achieved.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

Intra-operative (day 1)

Results posted on

2014-03-03

Participant Flow

Subjects who were scheduled for non-emergent, open hepatic surgery were assessed for potential study eligibility via a screening/baseline assessment performed within 30 days of their scheduled procedure.

Subjects who met the pre-operative eligibility criteria were considered for study participation. During the surgical procedures, subjects who met the intra-operative eligibility criteria were randomized. Subjects who did not meet all criteria were considered screen failures and not randomized.

Participant milestones

Participant milestones
Measure	Veriset Hemostatic Patch Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) Subject received the topical hemostat TachoSil®
Overall Study STARTED	32	18
Overall Study COMPLETED	31	16
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Veriset Hemostatic Patch Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) Subject received the topical hemostat TachoSil®
Overall Study Death	1	1
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Comparison of the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Veriset Hemostatic Patch n=32 Participants Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) n=18 Participants Subject received the topical hemostat TachoSil®	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants	6 Participants n=7 Participants	24 Participants n=5 Participants
Age, Continuous	62.2 years STANDARD_DEVIATION 14.9 • n=5 Participants	62 years STANDARD_DEVIATION 10.6 • n=7 Participants	62.1 years STANDARD_DEVIATION 13.4 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	11 Participants n=7 Participants	30 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment Belgium	11 participants n=5 Participants	5 participants n=7 Participants	16 participants n=5 Participants
Region of Enrollment Austria	6 participants n=5 Participants	4 participants n=7 Participants	10 participants n=5 Participants
Region of Enrollment Germany	15 participants n=5 Participants	9 participants n=7 Participants	24 participants n=5 Participants

PRIMARY outcome

Timeframe: Intra-operative (day 1)

Population: Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil®).

Outcome measures

Outcome measures
Measure	Veriset Hemostatic Patch n=32 Participants Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) n=17 Participants Subject received the topical hemostat TachoSil®.
Median Time to Achieve Hemostasis Following Application of Study Treatment.	1 Minutes Interval 0.5 to 4.0	3 Minutes Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: Intra-operative (day 1)

Population: Per the study protocol, the ITT population will serve as the primary analysis population for effectiveness and will be discussed in this report. One randomized subject, Subject 1104, did not receive the assigned treatment (TachoSil).

Outcome measures

Outcome measures
Measure	Veriset Hemostatic Patch n=32 Participants Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) n=17 Participants Subject received the topical hemostat TachoSil®.
Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application	30 Participants Interval 77.8 to 98.9	12 Participants Interval 46.0 to 88.0

SECONDARY outcome

Timeframe: Up to 30 days post surgery.

Population: All treated subjects are included in the Safety population.

Outcome measures

Outcome measures
Measure	Veriset Hemostatic Patch n=32 Participants Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) n=17 Participants Subject received the topical hemostat TachoSil®.
Number of Subjects With Treatment-emergent Adverse Events	23 Participants	14 Participants

Adverse Events

Veriset Hemostatic Patch

Serious events: 10 serious events

Other events: 22 other events

Deaths: 0 deaths

Fibrin Sealant (TachoSil®)

Serious events: 8 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Vice President, Medical Affairs

Covidien

Phone: 203-500-4256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Veriset Hemostatic Patch n=32 participants at risk Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) n=17 participants at risk Subject received the topical hemostat TachoSil®.
Gastrointestinal disorders Ascites	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
General disorders Multi-organ failure	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Hepatobiliary disorders Biloma	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Abdominal abscess	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Bronchopulmonary aspergillosis	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Device related sepsis	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Escherichia infection	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Haematoma infection	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Postoperative wound infection	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Pyothorax	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Post procedural bile leak	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Wound dehiscence	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Renal and urinary disorders Renal failure acute	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	6.2% 2/32 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Vascular disorders Haematoma	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Vascular disorders Inferior vena caval occlusion	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Vascular disorders Subclavian vein thrombosis	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.

Measure	Veriset Hemostatic Patch n=32 participants at risk Subject received the topical hemostat Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®) n=17 participants at risk Subject received the topical hemostat TachoSil®.
Cardiac disorders Atrial Fibrillation	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Abdominal compartment syndrome	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Abdominal pain	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Ascites	15.6% 5/32 • Number of events 6 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Flatulence	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Haemorrhoids	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Localised intraabdominal fluid collection	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Nausea	6.2% 2/32 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Papilla of Vater stenosis	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Gastrointestinal disorders Vomiting	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
General disorders Inflammation	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
General disorders Pyrexia	9.4% 3/32 • Number of events 3 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Hepatobiliary disorders Biloma	6.2% 2/32 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Hepatobiliary disorders Cholangitis	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Hepatobiliary disorders Hepatic failure	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Hepatobiliary disorders Hepatic function abnormal	12.5% 4/32 • Number of events 4 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Bacterial infection	6.2% 2/32 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Infection	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Pneumonia	6.2% 2/32 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Infections and infestations Postoperative wound infection	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Anaemia postoperative	6.2% 2/32 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	0.00% 0/17 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Post procedural bile leak	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Weaning failure	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Wound complication	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	17.6% 3/17 • Number of events 3 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Injury, poisoning and procedural complications Wound dehiscence	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	17.6% 3/17 • Number of events 3 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Investigations Haemoglobin decreased	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Investigations Hepatic enzyme increased	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	11.8% 2/17 • Number of events 2 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to chest wall	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to diaphragm	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Nervous system disorders Disturbance in attention	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Nervous system disorders Hepatic encephalopathy	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Nervous system disorders Parkinson's disease	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Renal and urinary disorders Renal failure	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Renal and urinary disorders Renal failure actute	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Renal and urinary disorders Urge incontinence	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Atelectasis	3.1% 1/32 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 4/32 • Number of events 5 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	17.6% 3/17 • Number of events 3 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Skin and subcutaneous tissue disorders Decubitus ulcer	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/32 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.	5.9% 1/17 • Number of events 1 • Adverse events were collected from the time of randomization through the 30 day follow-up visit.