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A Study of Fibrocaps in Liver Surgery in the Netherlands

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.
ClinicalTrials.gov Identifier: NCT01256190
Recruitment Status : Completed
First Posted : December 8, 2010
Results First Posted : May 15, 2014
Last Update Posted : August 22, 2016
Sponsor:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Postoperative Hemorrhage
Interventions: Biological: Fibrocaps (fibrin sealant)
Device: Gelatin sponge

  Participant Flow

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
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

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

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 
Overall Participants Analyzed 
[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

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

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 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: Lawrence Hill
Organization: Mallinckrodt
phone: 908-238-6370
e-mail: lawrence.hill@mallinckrodt.com



Responsible Party: Mallinckrodt
ClinicalTrials.gov Identifier: NCT01256190     History of Changes
Other Study ID Numbers: FC-002 NL
First Submitted: December 6, 2010
First Posted: December 8, 2010
Results First Submitted: April 11, 2013
Results First Posted: May 15, 2014
Last Update Posted: August 22, 2016