U.S. Study of Fibrocaps in Surgical Hemostasis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ProFibrix, Inc.
ClinicalTrials.gov Identifier:
NCT01256164
First received: December 6, 2010
Last updated: October 21, 2013
Last verified: October 2013
Results First Received: April 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Supportive Care
Condition: Postoperative Hemorrhage
Interventions: Device: Fibrocaps (fibrin sealant)
Device: Gelfoam

  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
Enrollment commenced in February 2011 and completed in October 2011 at 8 investigative study sites in the United States.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Approximately 90 eligible subjects were planned for enrollment, randomization, and treatment. The enrollment stopped short of the targeted 90 subjects due to enrollment of more subjects in the parallel study being conducted in the Netherlands.

Reporting Groups
  Description
Fibrocaps + Gelfoam After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
Gelfoam Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.

Participant Flow:   Overall Study
    Fibrocaps + Gelfoam     Gelfoam  
STARTED     47     23  
COMPLETED     47     23  
NOT COMPLETED     0     0  



  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
Fibrocaps + Gelfoam After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
Gelfoam Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
Total Total of all reporting groups

Baseline Measures
    Fibrocaps + Gelfoam     Gelfoam     Total  
Number of Participants  
[units: participants]
  47     23     70  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     26     13     39  
>=65 years     21     10     31  
Age  
[units: years]
Mean ± Standard Deviation
  59.0  ± 13.97     61.3  ± 10.48     59.8  ± 12.89  
Gender  
[units: participants]
     
Female     22     14     36  
Male     25     9     34  
Region of Enrollment  
[units: participants]
     
United States     47     23     70  



  Outcome Measures
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1.  Primary:   Mean Time to Hemostasis (TTH)   [ Time Frame: 0-10 minutes ]

2.  Secondary:   Safety   [ Time Frame: 28 Days ]

3.  Secondary:   Number of Subjects Achieving Hemostasis at 3 Minutes   [ Time Frame: 3 minutes ]

4.  Secondary:   Number of Participants Achieving Hemostasis at 5 Minutes   [ Time Frame: 5 minutes ]

5.  Secondary:   Number of Patients Achieving Hemostasis at 10 Minutes   [ Time Frame: 10 minutes ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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.  


Results Point of Contact:  
Name/Title: Paul Frohna, Chief Medical Officer
Organization: ProFibrix, Inc
phone: 206-499-6462
e-mail: p.frohna@profibrix.com


No publications provided


Responsible Party: ProFibrix, Inc.
ClinicalTrials.gov Identifier: NCT01256164     History of Changes
Other Study ID Numbers: FC-002
Study First Received: December 6, 2010
Results First Received: April 11, 2013
Last Updated: October 21, 2013
Health Authority: United States: Food and Drug Administration