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Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

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ClinicalTrials.gov Identifier: NCT00673439
Recruitment Status : Terminated (study terminated due to low accrual)
First Posted : May 7, 2008
Results First Posted : June 24, 2013
Last Update Posted : March 29, 2018
Sponsor:
Collaborator:
James Graham Brown Cancer Center
Information provided by (Responsible Party):
Goetz Kloecker, University of Louisville

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Heparin-Induced Thrombocytopenia
Interventions Drug: fondaparinux
Drug: warfarin
Enrollment 3
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 3
Completed 3
Not Completed 0
Arm/Group Title Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 3
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Over 18 years of age Number Analyzed 3 participants
3
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants
Female
2
  66.7%
Male
1
  33.3%
1.Primary Outcome
Title the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux
Hide Description Study terminated, results data not available
Time Frame at fondaparinux discontinuation
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
Hide Description [Not Specified]
Time Frame 4 weeks after INR reaches 2 or more
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
Hide Arm/Group Description [Not Specified]
All-Cause Mortality
Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
Affected / at Risk (%)
Total   0/3 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
Affected / at Risk (%)
Total   0/3 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Goetz H Kloecker, MD, MSPH
Organization: James Graham Brown Cancer Center
Phone: 502/562-4358
Responsible Party: Goetz Kloecker, University of Louisville
ClinicalTrials.gov Identifier: NCT00673439     History of Changes
Other Study ID Numbers: 07.0100
BCC-NON-07-001 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
First Submitted: May 5, 2008
First Posted: May 7, 2008
Results First Submitted: May 3, 2013
Results First Posted: June 24, 2013
Last Update Posted: March 29, 2018