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Fondaparinux in Preventing Blood Clots in Patients Undergoing Surgery for Gynecologic Cancer

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ClinicalTrials.gov Identifier: NCT00381888
Recruitment Status : Completed
First Posted : September 28, 2006
Results First Posted : January 27, 2010
Last Update Posted : December 28, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Cervical Cancer
Endometrial Cancer
Fallopian Tube Cancer
Ovarian Cancer
Sarcoma
Thromboembolism
Vaginal Cancer
Vulvar Cancer
Intervention: Drug: fondaparinux sodium

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Patients Enrolled and Consented This number includes all patients consented and enrolled in this study.

Participant Flow:   Overall Study
    Patients Enrolled and Consented
STARTED   44 
COMPLETED   27 
NOT COMPLETED   17 
Death                1 
Withdrawal by Subject                1 
Physician Decision                1 
Protocol Violation                9 
Had laparoscopic surgery                2 
Surgery was cancelled                2 
Adverse Event                1 



  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
Patients Enrolled and Consented This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.

Baseline Measures
   Patients Enrolled and Consented 
Overall Participants Analyzed 
[Units: Participants]
 44 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      36  81.8% 
>=65 years      8  18.2% 
Age 
[Units: Years]
Mean (Full Range)
 55.7 
 (28 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      44 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   44 


  Outcome Measures

1.  Primary:   Number of Patients With Venous Thromboembolism at Week 4   [ Time Frame: Week 4 (Days 28-35) ]

2.  Secondary:   Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.   [ Time Frame: Week 4 ]


  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
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  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Levi S. Downs, Jr., M.D.
Organization: Masonic Cancer Center, University of Minnesota
phone: 612-626-6628
e-mail: downs008@umn.edu



Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00381888     History of Changes
Other Study ID Numbers: CDR0000503985
UMN-2006LS009 ( Other Identifier: Clinical Trials Office, University of Minnesota )
UMN-0603M82707 ( Other Identifier: IRB, University of Minnesota )
First Submitted: September 26, 2006
First Posted: September 28, 2006
Results First Submitted: October 29, 2009
Results First Posted: January 27, 2010
Last Update Posted: December 28, 2017