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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:
ClinicalTrials.gov Identifier:
NCT01639833
First Posted: July 13, 2012
Last Update Posted: July 3, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medtronic - MITG
Results First Submitted: June 3, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Participant);   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.
No text entered.

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 
Overall Participants Analyzed 
[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



Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT01639833     History of Changes
Other Study ID Numbers: COVEUCV0140
First Submitted: July 11, 2012
First Posted: July 13, 2012
Results First Submitted: June 3, 2014
Results First Posted: July 3, 2014
Last Update Posted: July 3, 2014