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The Fibrin Pad Cardiovascular Study

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ClinicalTrials.gov Identifier: NCT01681030
Recruitment Status : Completed
First Posted : September 7, 2012
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Ethicon, Inc.

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cardiovascular Disease
Interventions: Biological: EVARREST™
Biological: Topical hemostat
Other: Standard of Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from September 17, 2012 through September 3, 2013 at hospitals and medical centers throughout the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
EVARREST Fibrin Sealant Patch EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
Topical Hemostat Equine collagen sponge with Human Fibrinogen and Human Thrombin
Standard of Care (SoC) SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.

Participant Flow:   Overall Study
    EVARREST Fibrin Sealant Patch   Topical Hemostat   Standard of Care (SoC)
STARTED   13   18   11 
COMPLETED   13   18   11 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

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.
Baseline data was summarized for Intent to Treat (ITT) Set, which included all randomized subjects.

Reporting Groups
  Description
EVARREST Fibrin Sealant Patch EVARREST® Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin.
Topical Hemostat Equine collagen sponge with Human Fibrinogen and Human Thrombin
Standard of Care (SoC) SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
Total Total of all reporting groups

Baseline Measures
   EVARREST Fibrin Sealant Patch   Topical Hemostat   Standard of Care (SoC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 13   18   11   42 
Age 
[Units: Years]
Mean (Standard Deviation)
       
Age   56.0  (15.1)   59.8  (12.9)   60.5  (15.4)   58.8  (14.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      4  30.8%      3  16.7%      2  18.2%      9  21.4% 
Male      9  69.2%      15  83.3%      9  81.8%      33  78.6% 
Race/Ethnicity, Customized 
[Units: Participants]
       
Asian   0   0   1   1 
Black or African American   2   0   2   4 
White/Caucasian   9   11   6   26 
Hispanic or Latino   2   7   2   11 
BMI Category [1] 
[Units: Participant]
       
Normal   5   7   4   16 
Overweight   3   5   2   10 
Obese   3   5   4   12 
Morbidly obese   2   1   1   4 
[1] Underweight: < 18.5 kg/m^2, Normal weight: 18.5 - <25 kg/m^2 , Overweight: 25 - <30 kg/m^2, Obese: 30 - <40 kg/m^2, Morbidly obese: 40 kg/m^2 or more


  Outcome Measures

1.  Primary:   Hemostasis at the Target Bleeding Site (TBS) at 3 Minutes Following Treatment Application.   [ Time Frame: Intraoperative, 3 minutes following treatment application ]

2.  Secondary:   Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application   [ Time Frame: Intraoperative, 6 minutes following treatment application ]

3.  Secondary:   Hemostasis at the Target Bleeding Site (TBS) at 10 Minutes Following Treatment Application   [ Time Frame: Intraoperative, 10 minutes following treatment application ]

4.  Secondary:   Bleeding at the Target Bleeding Site (TBS) Requiring Additional Treatment   [ Time Frame: Intra-operative, prior initiation of final chest wall closure. Safety Issue: ]

5.  Secondary:   Incidence of Adverse Events Potentially Related to Thrombotic Events   [ Time Frame: Intra-operative and up until 30 days (+ 14 days) following surgery ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Richard Kocharian, MD, PhD
Organization: Ethicon, Inc
phone: +1-908-218-2013
e-mail: rkochar1@its.jnj.com



Responsible Party: Ethicon, Inc.
ClinicalTrials.gov Identifier: NCT01681030     History of Changes
Other Study ID Numbers: 400-12-002
First Submitted: September 5, 2012
First Posted: September 7, 2012
Results First Submitted: November 13, 2017
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018