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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
Enrollment 44
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Patients Enrolled and Consented
Hide Arm/Group Description This number includes all patients consented and enrolled in this study.
Period Title: Overall Study
Started 44
Completed 27
Not Completed 17
Reason Not Completed
Death             1
Withdrawal by Subject             1
Physician Decision             1
Protocol Violation             9
Had laparoscopic surgery             2
Surgery was cancelled             2
Adverse Event             1
Arm/Group Title Patients Enrolled and Consented
Hide Arm/Group Description This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.
Overall Number of Baseline Participants 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
<=18 years
0
   0.0%
Between 18 and 65 years
36
  81.8%
>=65 years
8
  18.2%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 44 participants
55.7
(28 to 70)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants
Female
44
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 44 participants
44
1.Primary Outcome
Title Number of Patients With Venous Thromboembolism at Week 4
Hide Description Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system.
Time Frame Week 4 (Days 28-35)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number includes those patients who completed the study and are evaluable for this outcome measure.
Arm/Group Title Fondaparinux Patients Who Completed Study
Hide Arm/Group Description:
This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
0
2.Secondary Outcome
Title Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
Hide Description This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition.
Time Frame Week 4
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
These patients completed the study and are considered evaluable for this outcome measure.
Arm/Group Title Fondaparinux Patients Who Completed Study
Hide Arm/Group Description:
This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
Overall Number of Participants Analyzed 27
Measure Type: Number
Unit of Measure: Participants
27
Time Frame 4 Weeks
Adverse Event Reporting Description 33 of 44 patients received at least one dose of Fondaparinux and therefore have been assessed for toxicity.
 
Arm/Group Title All Patients Who Received at Least One Dose of Fondaparinux
Hide Arm/Group Description This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
All-Cause Mortality
All Patients Who Received at Least One Dose of Fondaparinux
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients Who Received at Least One Dose of Fondaparinux
Affected / at Risk (%) # Events
Total   7/33 (21.21%)    
Cardiac disorders   
Cardiac ischemia/infarction  1 [1]  1/33 (3.03%)  1
Gastrointestinal disorders   
Partial small bowel obstruction  1 [2]  1/33 (3.03%)  1
Small bowel obstruction  1 [3]  1/33 (3.03%)  1
Infections and infestations   
Colitis (C. difficile)  1 [4]  1/33 (3.03%)  1
Infection/Sepsis  1 [1]  1/33 (3.03%)  1
Port-a-cath infection  1 [4]  1/33 (3.03%)  1
Wound infection  1 [2]  1/33 (3.03%)  1
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1 [1]  1/33 (3.03%)  1
Vascular disorders   
Pulmonary embolism, post-op  1 [5]  1/33 (3.03%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Grade 5, death
[2]
Grade 2, moderate
[3]
Grade 4, life threatening
[4]
Grade 3, severe
[5]
Grade 4, life-threatening
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
All Patients Who Received at Least One Dose of Fondaparinux
Affected / at Risk (%) # Events
Total   23/33 (69.70%)    
Blood and lymphatic system disorders   
Hematoma, retroperitoneal  1  1/33 (3.03%)  1
Cardiac disorders   
Bradycardia  1  1/33 (3.03%)  1
Tachycardia  1  2/33 (6.06%)  2
Gastrointestinal disorders   
Decreased appetite (anorexia)  1  1/33 (3.03%)  1
Dehyration  1  1/33 (3.03%)  1
Diarrhea  1  1/33 (3.03%)  2
Emesis (vomiting)  1  4/33 (12.12%)  4
Heartburn (dyspepsia)  1  1/33 (3.03%)  1
Nausea  1  5/33 (15.15%)  5
General disorders   
Chills  1  1/33 (3.03%)  1
Fever  1  5/33 (15.15%)  7
Pain, chest  1  1/33 (3.03%)  1
Sleeplessness  1  1/33 (3.03%)  1
Infections and infestations   
Infection, wound  1  1/33 (3.03%)  1
Urinary tract infection  1  3/33 (9.09%)  3
Metabolism and nutrition disorders   
Hypokalemia  1  1/33 (3.03%)  1
Hypomagnesemia  1  1/33 (3.03%)  1
Nervous system disorders   
Anxiety, increased  1  1/33 (3.03%)  1
Cold sensation, upper thighs & lower abdomen  1  1/33 (3.03%)  2
Numbness (paresthesia), upper thighs, lower extremity, abdomen  1  2/33 (6.06%)  3
Vertigo  1  1/33 (3.03%)  1
Renal and urinary disorders   
Dysuria  1  1/33 (3.03%)  1
Urine output, low  1  1/33 (3.03%)  1
Reproductive system and breast disorders   
Vaginal discharge  1  1/33 (3.03%)  2
Respiratory, thoracic and mediastinal disorders   
Atelectasis  1  1/33 (3.03%)  1
Dyspnea  1  1/33 (3.03%)  1
Hypoxia (oxygen desaturation)  1  3/33 (9.09%)  3
Lung crackles  1  1/33 (3.03%)  1
Sleep apnea  1  1/33 (3.03%)  1
Skin and subcutaneous tissue disorders   
Bruising  1  7/33 (21.21%)  7
Wound, draining  1  3/33 (9.09%)  3
Wound, open  1  4/33 (12.12%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
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