A Study of Fibrocaps in Liver Surgery in the Netherlands

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ProFibrix, Inc.
ClinicalTrials.gov Identifier:
NCT01256190
First received: December 6, 2010
Last updated: June 9, 2014
Last verified: June 2014
Results First Received: April 11, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Postoperative Hemorrhage
Interventions: Biological: Fibrocaps (fibrin sealant)
Device: Gelatin sponge

  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 December 2010 and completed in October 2011 from 5 academic medical centers in the Netherlands

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
None

Reporting Groups
  Description
Fibrocaps + Gelatin Sponge Topical Fibrocaps powder followed by application of gelatin sponge
Gelatin Sponge approved device for surgical bleeding

Participant Flow:   Overall Study
    Fibrocaps + Gelatin Sponge     Gelatin Sponge  
STARTED     39     17  
COMPLETED     37     17  
NOT COMPLETED     2     0  
Lost to Follow-up                 2                 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 + Gelatin Sponge Topical Fibrocaps powder followed by application of gelatin sponge
Gelatin Sponge approved device for surgical bleeding
Total Total of all reporting groups

Baseline Measures
    Fibrocaps + Gelatin Sponge     Gelatin Sponge     Total  
Number of Participants  
[units: participants]
  39     17     56  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     23     11     34  
>=65 years     16     6     22  
Age  
[units: years]
Mean ± Standard Deviation
  60  ± 13     64  ± 9     61  ± 12  
Gender  
[units: participants]
     
Female     14     6     20  
Male     25     11     36  
Region of Enrollment  
[units: participants]
     
Netherlands     39     17     56  



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

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

3.  Secondary:   Incidence of Hemostasis at 5 Minutes   [ Time Frame: 5 minutes ]

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

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


  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
No text entered.


  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.


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: NCT01256190     History of Changes
Other Study ID Numbers: FC-002 NL
Study First Received: December 6, 2010
Results First Received: April 11, 2013
Last Updated: June 9, 2014
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)