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

• Sponsor: Medtronic - MITG (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01324349
• Collaborator: (none)
• Enrollment: 50
• Locations: 6
• Arms: 2
• Duration (Months): 7
• Patients Per Site: 8.3
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Covidien's Hemostatic Patch to control bleeding during hepatic surgery. The performance of the Hemostatic Patch will be compared to Control as an adjunct to conventional hemostatic techniques.

Condition or Disease	Intervention/Treatment	Phase
Liver Disease	Device: Veriset Hemostatic Patch; Device: Fibrin Sealant (TachoSil®)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective, Multi-Center, Randomized, Single-Blind Study to Compare the Hemostatic Patch to Fibrin Sealant (TachoSil®) in Subjects Undergoing Hepatic Surgery
• Study Start Date: Feb 1, 2011
• Actual Primary Completion Date: Sep 1, 2011
• Actual Study Completion Date: Sep 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Veriset Hemostatic Patch Veriset Hemostatic Patch	Device: Veriset Hemostatic Patch; Topical hemostat
Active Comparator: Fibrin Sealant (TachoSil®) Fibrin Sealant (TachoSil®)	Device: Fibrin Sealant (TachoSil®); Topical hemostat

Outcome Measures

Primary Outcome Measures

1. Median Time to Achieve Hemostasis Following Application of Study Treatment. [Intra-operative (day 1)]

   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.

Secondary Outcome Measures

1. Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application [Intra-operative (day 1)]

   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.

2. Number of Subjects With Treatment-emergent Adverse Events [Up to 30 days post surgery.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Major Inclusion Criteria:

• Scheduled for non-emergent, hepatic surgery

• Presence of an appropriate target bleeding site (TBS) as defined by the protocol

Major Exclusion Criteria:

• Subject will be undergoing a laparoscopic hepatic procedure where the Hemostatic Patch will be delivered and applied through a trocar

• In subjects with documented history of cirrhosis, subject has uncorrected platelet count <60,000 per mm³ as determined by laboratory tests performed immediately prior to surgery

• Subject has severe coagulopathy defined as INR > 2.0

• Subject has Total Bilirubin >2.5mg/dL

• Subject has an active local infection at the Target Bleeding Site

• Study procedure involves a liver transplant recipient

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Innsbruck		Austria
2		Gent		Belgium
3		Leuven		Belgium
4		Hannover		Germany
5		Heidelberg		Germany
6		München		Germany

Sponsors and Collaborators

• Medtronic - MITG

Investigators

• Study Director: Amy Pollack, MD, Medtronic - MITG

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Medtronic - MITG
• ClinicalTrials.gov Identifier: NCT01324349
• Other Study ID Numbers: COVEULV0032
• First Posted: Mar 29, 2011
• Last Update Posted: Mar 3, 2014
• Last Verified: Jan 1, 2014

• Keywords provided by Medtronic - MITG: Hepatic; Topical Hemostat
• Additional relevant MeSH terms: Liver Diseases; Fibrin Tissue Adhesive; Hemostatics

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	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.

Arm/Group Title	Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®)
Arm/Group Description	Subject received the topical hemostat Veriset Hemostatic Patch	Subject received the topical hemostat TachoSil®
Period Title: Overall Study
STARTED	32	18
COMPLETED	31	16
NOT COMPLETED	1	2

Baseline Characteristics

Arm/Group Title	Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®)	Total
Arm/Group Description	Subject received the topical hemostat Veriset Hemostatic Patch	Subject received the topical hemostat TachoSil®	Total of all reporting groups
Overall Participants	32	18	50
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	14 43.8%	12 66.7%	26 52%
>=65 years	18 56.3%	6 33.3%	24 48%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.2 (14.9)	62 (10.6)	62.1 (13.4)
Sex: Female, Male (Count of Participants)
Female	19 59.4%	11 61.1%	30 60%
Male	13 40.6%	7 38.9%	20 40%
Region of Enrollment (participants) [Number]
Belgium	11 34.4%	5 27.8%	16 32%
Austria	6 18.8%	4 22.2%	10 20%
Germany	15 46.9%	9 50%	24 48%

Outcome Measures

1. Primary Outcome

Title	Median Time to Achieve Hemostasis Following Application of Study Treatment.
Description	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.
Time Frame	Intra-operative (day 1)

Outcome Measure Data

Analysis Population Description

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®).

Arm/Group Title	Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®)
Arm/Group Description	Subject received the topical hemostat Veriset Hemostatic Patch	Subject received the topical hemostat TachoSil®.
Measure Participants	32	17
Median (Full Range) [Minutes]	1	3

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Veriset Hemostatic Patch, Fibrin Sealant (TachoSil®)
	Comments	The primary effectiveness endpoint was time to hemostasis. The Kaplan-Meier method was used to estimate the survival distribution and to obtain the estimated median time to hemostasis for each treatment. Subjects who did not achieve hemostasis by 10 minutes were to be censored as of that time point. For each treatment, 95% Brookmeyer-Crowley confidence intervals for the median were computed based upon the sign test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.0001
	Comments
	Method	Log Rank
	Comments
Method of Estimation	Estimation Parameter	Median Difference (Final Values)
	Estimated Value	2
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Median difference equals control median minus Hemostatic Patch median in minutes.

2. Secondary Outcome

Title	Number of Subjects to Achieve Hemostasis Within 3 Minutes of Study Treatment Application
Description	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.
Time Frame	Intra-operative (day 1)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®)
Arm/Group Description	Subject received the topical hemostat Veriset Hemostatic Patch	Subject received the topical hemostat TachoSil®.
Measure Participants	32	17
Number [Participants]	30 93.8%	12 66.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Veriset Hemostatic Patch, Fibrin Sealant (TachoSil®)
	Comments	The secondary effectiveness endpoint was hemostasis within 3 minutes. The number and percentage of subjects who achieved hemostasis within 3 minutes are presented for each treatment group. The proportions of subjects who achieved hemostasis within 3 minutes were compared between treatments using the Suissa and Shuster test. Additionally, a 95% Blyth-Still-Casella confidence interval for the true proportion was computed for each treatment.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.0339
	Comments
	Method	Suissa and Shuster test
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	23.2
	Confidence Interval	(2-Sided) 95%; 1.9 to 47.3
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference equals percentage hemostasis for Hemostatic Patch minus percentage hemostasis for control.

3. Secondary Outcome

Title	Number of Subjects With Treatment-emergent Adverse Events
Time Frame	Up to 30 days post surgery.

Outcome Measure Data

Analysis Population Description

All treated subjects are included in the Safety population.

Arm/Group Title	Veriset Hemostatic Patch	Fibrin Sealant (TachoSil®)
Arm/Group Description	Subject received the topical hemostat Veriset Hemostatic Patch	Subject received the topical hemostat TachoSil®.
Measure Participants	32	17
Number [Participants]	23 71.9%	14 77.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Veriset Hemostatic Patch, Fibrin Sealant (TachoSil®)
	Comments	The incidence of subjects experiencing treatment-emergent adverse events (TEAEs) (defined under this protocol as Adverse Events) was summarized by MedDRA system organ class (SOC) and preferred term (PT) for each treatment group for the safety population. Tests for differences between the two treatments in the proportion of subjects experiencing any adverse event were made using Fisher's Exact Test.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5029
	Comments
	Method	Fisher Exact
	Comments
Method of Estimation	Estimation Parameter	Risk Difference (RD)
	Estimated Value	10.5
	Confidence Interval	() %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	Risk difference equals percent of subjects with any treatment emergent adverse events in control group minus percent of subjects with any treatment emergent adverse events in Hemostatic Patch group.

Adverse Events

Time Frame	Adverse events were collected from the time of randomization through the 30 day follow-up visit.
Arm/Group Title	Veriset Hemostatic Patch		Fibrin Sealant (TachoSil®)
Arm/Group Description	Subject received the topical hemostat Veriset Hemostatic Patch		Subject received the topical hemostat TachoSil®.
All Cause Mortality
	Veriset Hemostatic Patch		Fibrin Sealant (TachoSil®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Veriset Hemostatic Patch		Fibrin Sealant (TachoSil®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/32 (31.3%)		8/17 (47.1%)
Gastrointestinal disorders
Ascites	0/32 (0%)	0	1/17 (5.9%)	1
General disorders
Multi-organ failure	1/32 (3.1%)	1	1/17 (5.9%)	1
Hepatobiliary disorders
Biloma	1/32 (3.1%)	1	0/17 (0%)	0
Infections and infestations
Abdominal abscess	1/32 (3.1%)	1	0/17 (0%)	0
Bronchopulmonary aspergillosis	1/32 (3.1%)	1	0/17 (0%)	0
Device related sepsis	1/32 (3.1%)	1	0/17 (0%)	0
Escherichia infection	0/32 (0%)	0	1/17 (5.9%)	1
Haematoma infection	1/32 (3.1%)	1	0/17 (0%)	0
Postoperative wound infection	0/32 (0%)	0	2/17 (11.8%)	2
Pyothorax	0/32 (0%)	0	1/17 (5.9%)	1
Injury, poisoning and procedural complications
Post procedural bile leak	1/32 (3.1%)	1	0/17 (0%)	0
Post procedural haemorrhage	0/32 (0%)	0	1/17 (5.9%)	1
Wound dehiscence	1/32 (3.1%)	1	0/17 (0%)	0
Renal and urinary disorders
Renal failure acute	1/32 (3.1%)	1	1/17 (5.9%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism	2/32 (6.3%)	2	0/17 (0%)	0
Vascular disorders
Haematoma	1/32 (3.1%)	1	0/17 (0%)	0
Inferior vena caval occlusion	1/32 (3.1%)	1	0/17 (0%)	0
Subclavian vein thrombosis	1/32 (3.1%)	1	0/17 (0%)	0
Other (Not Including Serious) Adverse Events
	Veriset Hemostatic Patch		Fibrin Sealant (TachoSil®)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	22/32 (68.8%)		10/17 (58.8%)
Cardiac disorders
Atrial Fibrillation	0/32 (0%)	0	1/17 (5.9%)	1
Gastrointestinal disorders
Abdominal compartment syndrome	0/32 (0%)	0	1/17 (5.9%)	1
Abdominal pain	1/32 (3.1%)	1	1/17 (5.9%)	1
Abdominal pain upper	0/32 (0%)	0	1/17 (5.9%)	1
Ascites	5/32 (15.6%)	6	1/17 (5.9%)	1
Flatulence	0/32 (0%)	0	1/17 (5.9%)	1
Haemorrhoids	0/32 (0%)	0	1/17 (5.9%)	1
Localised intraabdominal fluid collection	0/32 (0%)	0	2/17 (11.8%)	2
Nausea	2/32 (6.3%)	2	2/17 (11.8%)	2
Papilla of Vater stenosis	0/32 (0%)	0	1/17 (5.9%)	1
Vomiting	1/32 (3.1%)	1	2/17 (11.8%)	2
General disorders
Inflammation	0/32 (0%)	0	1/17 (5.9%)	1
Pyrexia	3/32 (9.4%)	3	2/17 (11.8%)	2
Hepatobiliary disorders
Biloma	2/32 (6.3%)	2	0/17 (0%)	0
Cholangitis	0/32 (0%)	0	1/17 (5.9%)	1
Hepatic failure	0/32 (0%)	0	1/17 (5.9%)	1
Hepatic function abnormal	4/32 (12.5%)	4	1/17 (5.9%)	1
Infections and infestations
Bacterial infection	2/32 (6.3%)	2	0/17 (0%)	0
Infection	1/32 (3.1%)	1	1/17 (5.9%)	1
Pneumonia	2/32 (6.3%)	2	0/17 (0%)	0
Postoperative wound infection	1/32 (3.1%)	1	1/17 (5.9%)	1
Injury, poisoning and procedural complications
Anaemia postoperative	2/32 (6.3%)	2	0/17 (0%)	0
Post procedural bile leak	0/32 (0%)	0	1/17 (5.9%)	1
Weaning failure	0/32 (0%)	0	1/17 (5.9%)	1
Wound complication	0/32 (0%)	0	3/17 (17.6%)	3
Wound dehiscence	1/32 (3.1%)	1	3/17 (17.6%)	3
Investigations
Haemoglobin decreased	0/32 (0%)	0	1/17 (5.9%)	1
Hepatic enzyme increased	0/32 (0%)	0	2/17 (11.8%)	2
Musculoskeletal and connective tissue disorders
Back pain	0/32 (0%)	0	2/17 (11.8%)	2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to chest wall	0/32 (0%)	0	1/17 (5.9%)	1
Metastases to diaphragm	0/32 (0%)	0	1/17 (5.9%)	1
Nervous system disorders
Disturbance in attention	1/32 (3.1%)	1	1/17 (5.9%)	1
Hepatic encephalopathy	0/32 (0%)	0	1/17 (5.9%)	1
Parkinson's disease	0/32 (0%)	0	1/17 (5.9%)	1
Renal and urinary disorders
Renal failure	0/32 (0%)	0	1/17 (5.9%)	1
Renal failure actute	1/32 (3.1%)	1	1/17 (5.9%)	1
Urge incontinence	0/32 (0%)	0	1/17 (5.9%)	1
Respiratory, thoracic and mediastinal disorders
Atelectasis	1/32 (3.1%)	1	1/17 (5.9%)	1
Cough	0/32 (0%)	0	1/17 (5.9%)	1
Pleural effusion	4/32 (12.5%)	5	3/17 (17.6%)	3
Skin and subcutaneous tissue disorders
Decubitus ulcer	0/32 (0%)	0	1/17 (5.9%)	1
Drug eruption	0/32 (0%)	0	1/17 (5.9%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.