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TASALL - TachoSil® Against Liquor Leak

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ClinicalTrials.gov Identifier: NCT01355627
Recruitment Status : Completed
First Posted : May 18, 2011
Results First Posted : July 25, 2014
Last Update Posted : July 25, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Cerebrospinal Fluid Leaks
Interventions: Procedure: TachoSil®
Procedure: Current Practice

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants took part in the study at thirty-five Centres in a total of 10 countries: Belgium, France, Germany, Greece, Italy The Netherlands, Poland, Russia, Spain and Sweden from 28 April 2011 to 27 June 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants requiring dura sealing techniques for the prevention of post-operative cerebrospinal fluid (CSF) leaks were enrolled; 726 participants were randomized equally in 1 of 2 treatment groups, TachoSil® or Current practice group.

Reporting Groups
  Description
TachoSil® Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
Current Practice Group Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.

Participant Flow:   Overall Study
    TachoSil®   Current Practice Group
STARTED   362   364 
Safety Analysis Set   362   364 
Full Analysis Set   361 [1]   365 [2] 
COMPLETED   329   326 
NOT COMPLETED   33   38 
Request By the Patient to Discontinue                5                7 
Lost to Follow-up                8                7 
Fatal Adverse Event                19                23 
Other                1                1 
[1] One participant's data for final follow-up is missing, completion status could not be confirmed.
[2] One participant randomized to Current Practice actually received TachoSil®.



  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 Measures were based on the Full Analysis Set that included all enrolled randomized patients.

Reporting Groups
  Description
TachoSil® Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
Current Practice Group Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
Total Total of all reporting groups

Baseline Measures
   TachoSil®   Current Practice Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 361   365   726 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.1  (13.80)   53.2  (14.22)   53.1  (14.00) 
Age, Customized 
[Units: Participants]
     
18-65 years   288   293   581 
>65 years   73   72   145 
Gender 
[Units: Participants]
     
Female   233   211   444 
Male   128   154   282 
Race/Ethnicity, Customized 
[Units: Participants]
     
White/Caucasian   355   361   716 
Asian   1   0   1 
Black or African American   3   2   5 
American Indian or Alaska Native   1   1   2 
Other   1   1   2 
Race/Ethnicity, Customized 
[Units: Participants]
     
Hispanic or Latino   55   62   117 
Non-Hispanic and Non-Latino   295   289   584 
Unknown   11   14   25 
Region of Enrollment 
[Units: Participants]
     
Belgium   87   87   174 
Germany   33   29   62 
Spain   54   54   108 
France   24   26   50 
Greece   34   38   72 
Italy   14   14   28 
Netherlands   3   2   5 
Poland   59   61   120 
Russian Federation   9   8   17 
Sweden   44   46   90 
Height 
[Units: Cm]
Mean (Standard Deviation)
 167.4  (9.44)   168.5  (9.18)   168.0  (9.32) 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 73.6  (14.40)   75.2  (16.79)   74.4  (15.65) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 26.20  (4.44)   26.42  (5.10)   26.31  (4.79) 
Fertility Status 
[Units: Participants]
     
Fertile   74   74   148 
Post-Menopausal   140   111   251 
Surgically Sterile   19   26   45 
Not Applicable   128   154   282 


  Outcome Measures

1.  Primary:   Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure   [ Time Frame: Up to 8 Weeks (7 Weeks ± 1 Week) ]

2.  Secondary:   Percentage of Participants With Post-Surgical Non-Clinically Evident Post-Operative Pseudomeningocele   [ Time Frame: Assessment at least once prior to discharge from neurosurgical ward, with the expected discharge from neurosurgical ward after an average of 10 days (Up to 28 Weeks) ]


  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: Medical Director, Clinical Science
Organization: Takeda
phone: 800-778-2860
e-mail: clinicaltrialregistry@tpna.com



Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01355627     History of Changes
Other Study ID Numbers: TC-2402-038-SP
First Submitted: May 11, 2011
First Posted: May 18, 2011
Results First Submitted: June 26, 2014
Results First Posted: July 25, 2014
Last Update Posted: July 25, 2014