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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

  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
No text entered.

Reporting Groups
  Description
Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg) No text entered.

Participant Flow:   Overall Study
    Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg)
STARTED   3 
COMPLETED   3 
NOT COMPLETED   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
Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg) No text entered.

Baseline Measures
   Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg) 
Overall Participants Analyzed 
[Units: Participants]
 3 
Age, Customized 
[Units: Participants]
 
Over 18 years of age   3 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2  66.7% 
Male      1  33.3% 


  Outcome Measures

1.  Primary:   the Incidence of Clinically Significant Bleeding, Defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux   [ Time Frame: at fondaparinux discontinuation ]

2.  Secondary:   the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux   [ Time Frame: 4 weeks after INR reaches 2 or more ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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
Study terminated, results data not available


  More Information

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
e-mail: ghkloe01@exchange.edu



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