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| ID | Type | Description | Link |
|---|---|---|---|
| BCC-NON-07-001 | Other Identifier | James Graham Brown Cancer Center Clinical Trials Office |
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study terminated due to low accrual
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| Name | Class |
|---|---|
| James Graham Brown Cancer Center | OTHER |
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The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).
Currently, standard treatment of HIT involves the transition from a direct thrombin inhibitor (a type of anticoagulant or "blood thinner") to warfarin, a different type of anticoagulant. Direct thrombin inhibitors (DTIs) require IV administration and frequent blood draws for dose adjustments, which can lead to prolonged hospitalization. DTIs also affect blood test measurements, making it difficult to determine proper dosages of warfarin.
Fondaparinux is a drug that is approved by the FDA for the treatment of blood clots in deep veins and in the lungs. Fondaparinux is not FDA approved for the treatment of HIT. However, an increasing number of doctors are using fondaparinux instead of DTIs to treat HIT. Although fondaparinux appears to be more convenient and predictable than DTI medications, more research is needed to support its use as a treatment for HIT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fondaparinux | Experimental | daily subcutaneous injection of fondaparinux (7.5-10 mg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fondaparinux | Drug | Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Showing Clinically Significant Bleeding | Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux | 4 weeks after INR reaches 2 or more |
| Measure | Description | Time Frame |
|---|---|---|
| the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux | 4 weeks after INR reaches 2 or more |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Goetz H Kloecker, MD, MSPH | James Graham Brown Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Louisville Hospital | Louisville | Kentucky | 40202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fondaparinux | daily subcutaneous injection of fondaparinux (7.5-10 mg) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fondaparinux | daily subcutaneous injection of fondaparinux (7.5-10 mg) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Showing Clinically Significant Bleeding | Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux | Posted | Number | participants | 4 weeks after INR reaches 2 or more |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Daily Subcutaneous Injection of Fondaparinux (7.5-10 mg) |
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Study terminated, results data not available
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Goetz H Kloecker, MD, MSPH | James Graham Brown Cancer Center | 502/562-4358 | ghkloe01@exchange.edu |
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| ID | Term |
|---|---|
| D013921 | Thrombocytopenia |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001791 | Blood Platelet Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000095542 | Cytopenia |
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| ID | Term |
|---|---|
| D000077425 | Fondaparinux |
| D014859 | Warfarin |
| ID | Term |
|---|---|
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D015110 | 4-Hydroxycoumarins |
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|
| warfarin | Drug | Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks |
|
|
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux | Posted | Count of Participants | Participants | 4 weeks after INR reaches 2 or more |
|
|
|
| 0 |
| 3 |
| 0 |
| 3 |
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| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D003374 |
| Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |