A Premarket, Prospective, Randomized, Single-Blind Study to Compare the Veriset™ Hemostatic Patch to TachoSil® as an Adjunct to Hemostasis in Subjects Undergoing Cardiovascular Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Covidien
ClinicalTrials.gov Identifier:
NCT01639833
First received: July 11, 2012
Last updated: June 3, 2014
Last verified: June 2014
Results First Received: June 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Conditions: Cardiac Surgical Procedures
Hemorrhage
Interventions: Device: Veriset Hemostatic Patch
Device: TachoSil®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Veriset™ Hemostatic Patch

Topical Hemostat

Veriset™ Hemostatic Patch: Topical hemostat

TachoSil®

Topical Hemostat

TachoSil®: Topical Hemostat


Participant Flow:   Overall Study
    Veriset™ Hemostatic Patch     TachoSil®  
STARTED     45     45  
COMPLETED     39     41  
NOT COMPLETED     6     4  
Death                 4                 2  
Withdrawal by Subject                 2                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Veriset™ Hemostatic Patch

Topical Hemostat

Veriset™ Hemostatic Patch: Topical hemostat

TachoSil®

Topical Hemostat

TachoSil®: Topical Hemostat

Total Total of all reporting groups

Baseline Measures
    Veriset™ Hemostatic Patch     TachoSil®     Total  
Number of Participants  
[units: participants]
  45     45     90  
Age  
[units: years]
Mean ± Standard Deviation
  68.5  ± 12.2     66.7  ± 13.4     67.6  ± 12.7  
Gender  
[units: participants]
     
Female     16     13     29  
Male     29     32     61  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     45     44     89  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     1     0     1  
Not Hispanic or Latino     44     45     89  
Unknown or Not Reported     0     0     0  
Height  
[units: centimeters]
Mean ± Standard Deviation
  171.3  ± 9.1     170.8  ± 10.4     171.1  ± 9.7  
Weight  
[units: kilograms]
Mean ± Standard Deviation
  81.67  ± 14.27     81.96  ± 17.27     81.82  ± 15.75  



  Outcome Measures
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1.  Primary:   Time to Hemostasis (TTH)   [ Time Frame: Day 0 ]

2.  Secondary:   Hemostasis at All Treated Bleeding Sites Within 3 Minutes   [ Time Frame: Day 0 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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.


Results Point of Contact:  
Name/Title: Michael Rohan
Organization: Covidien
phone: 781-839-1757
e-mail: Michael.Rohan@Covidien.com


No publications provided


Responsible Party: Covidien
ClinicalTrials.gov Identifier: NCT01639833     History of Changes
Other Study ID Numbers: COVEUCV0140
Study First Received: July 11, 2012
Results First Received: June 3, 2014
Last Updated: June 3, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products