A Comparative Sudy Comparing Argatroban® IV vs Desirudin SC for Suspected HIT With or Without Thrombosis Syndrome
Condition: Suspected Heparin-Induced Thrombocytopenia
MeSH terms: Thrombosis; Thrombocytopenia
Intervention: Desirudin or Argatroban®
Intervention description: Desirudin 15mg SC Argatroban® IV dosing per Package Insert
Intervention MeSH terms: Desirudin; Argatroban
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Suspected Heparin Induced Thrombocytopenia (HIT)

Summary:

      Compare Clinical Success and Costs in two Arms
    

Eligibility criteria:

        Inclusion Criteria:

          1. Provide written Informed Consent

          2. Be at least 18 years of age.

          3. A suspicion of heparin-induced thrombocytopenia with or without thrombosis syndrome
             (HIT/TS) due to one of the following clinical scenarios:

               1. Patients who are receiving heparin/LMWH or have received heparin/LMWH within the
                  previous 100 days AND one of the following:

                    -  have a fall in platelet count of > 30% from a baseline prior to
                       heparin/LMWH, OR

                    -  have a thrombotic event, OR

                    -  develop skin lesions secondary to subcutaneous heparin (even if the patient
                       is no longer receiving heparin therapy when thrombocytopenia, thrombosis or
                       skin lesions occur).

                  Patients with thrombosis or skin lesions need not have concomitant
                  thrombocytopenia to be included.

               2. A rapid fall in the platelet count by >30% from baseline within 24 hours after
                  starting heparin/LMWH in patients with suspected exposure to heparin or LMWH in
                  the previous 100 days (e.g. hospitalization or invasive procedure within the past
                  100 days).

               3. In post-operative cardiac surgery patients, development of thrombocytopenia
                  defined as a decrease in platelet count by >30% from the post-operative peak; or
                  patients whose platelet count fails to increase post-operatively (e.g. remains <
                  100,000 mm3 at Day 4 or later, calendar day of surgery=Day 0).

          4. In patients with the diagnosis of HIT/TS established by a hematology consultant, but
             in whom the above criteria are not fulfilled, the Investigator should contact the
             Medical Monitor for consideration of the patient's inclusion in this study (A
             hematology consult is highly advisable, but not required prior to randomization).

        Exclusion Criteria:

          -  Confirmed pregnancy (if woman of child-bearing potential- urine or serum pregnancy
             test).

          -  Patients with suspected or confirmed pulmonary embolism, requiring continued
             anticoagulation or acute ischemic stroke will be excluded

          -  Cerebrovascular accident within the previous 6 months

          -  Intracranial neoplasm, arteriovenous malformation or aneurysm.

          -  Severe renal insufficiency as determined by measured or estimated creatinine clearance
             < 30 ml/min.

          -  Known allergy to Argatroban®, Desirudin or hirudin derived drugs, or known sensitivity
             to any component of the product

          -  Patients receiving recombinant hirudin (e.g. lepirudin) within the previous 6 months
             prior to enrollment.

          -  Patients receiving >2 doses of fondaparinux for treatment of suspected HIT

          -  Multi-system organ failure or estimated survival of less than 30 days.

          -  Participation in other clinical research studies involving the evaluation of other
             investigational drugs or devices within 30 days of enrollment

          -  Refusal to undergo blood transfusion should it become necessary

          -  Active bleeding or irreversible coagulation abnormality

          -  Uncontrolled hypertension defined as a blood pressure >180/110 mm Hg.

          -  Patients requiring indwelling mechanical intervention such as left-ventricular assist
             device, intra-aortic balloon pump, veno-venous ultra filtration, etc.

          -  Severe liver disease and any other disease or condition, which, in the judgment of the
             Investigator, would place a patient at undue risk by being enrolled in the trial, or
             cause inability to comply with the trial.