Heparin-Induced Thrombocytopenia
Conditions
Keywords
heparin-induced thrombocytopenia, thrombocytopenia, HIT, thrombosis, blood clot, blood thinner, anticoagulant, heparin, warfarin, fondaparinux, Arixtra
Brief summary
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).
Detailed description
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.
Interventions
DRUGfondaparinux
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
DRUGwarfarin
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
Sponsors
James Graham Brown Cancer Center
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* high risk for HIT based on Four Ts score of 6 or more
Exclusion criteria
* pulmonary emboli at the time of enrollment * arterial thrombosis at the time of enrollment * limb threatening phlegmasia cerulea dolens at the time of enrollment * Calculated Creatinin Clearance less than 50 ml/hr * platelet count less than 50 * Weight less than 50 kg * pregnancy * allergy to fondaparinux * bacterial endocarditis * history of neuraxial anesthesia and post-operative indwelling epidural catheter * active major bleeding (hemodynamically significant or requiring transfusions) * inability to give informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Showing Clinically Significant Bleeding | 4 weeks after INR reaches 2 or more | Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux |
Secondary
| Measure | Time frame |
|---|---|
| the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux | 4 weeks after INR reaches 2 or more |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fondaparinux daily subcutaneous injection of fondaparinux (7.5-10 mg) | 3 |
| Total | 3 |
Baseline characteristics
| Characteristic | Fondaparinux |
|---|---|
| Age, Customized Over 18 years of age | 3 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 3 |
| serious Total, serious adverse events | 0 / 3 |
Outcome results
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
Time frame: 4 weeks after INR reaches 2 or more
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fondaparinux | Number of Participants Showing Clinically Significant Bleeding | 0 participants |
Secondary
the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
Time frame: 4 weeks after INR reaches 2 or more
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fondaparinux | the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux | 0 Participants |