Suspected Heparin-Induced Thrombocytopenia
Conditions
Keywords
Suspected Heparin Induced Thrombocytopenia (HIT)
Brief summary
Compare Clinical Success and Costs in two Arms
Detailed description
Demonstrate clinical and economic utility between the study Arms.
Interventions
DRUGDesirudin or Argatroban®
Desirudin 15mg SC Argatroban® IV dosing per Package Insert
Sponsors
Canyon Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New Thrombosis, Amputation, Death, Major and Minor Bleeding | 30 days |
Countries
United States
Participant flow
Recruitment details
Patients were enrolled between November 2008 and December 2009 from approximately 20 US Medical Centers
Pre-assignment details
Patients were excluded if they had severe renal failure (CrCL\<30 mL/min), known allergy to r-hirudins or argatroban, multisystem organ failure, uncontrolled bleeding.
Participants by arm
| Arm | Count |
|---|---|
| Desirudin Patients with suspected HIT randomized to SC Desirudin i | 8 |
| Argatroban® Patients with suspected HIT randomized to IV Argatroban® | 8 |
| Total | 16 |
Baseline characteristics
| Characteristic | Argatroban® | Desirudin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 6 Participants | 12 Participants |
| Age Continuous | 62 years STANDARD_DEVIATION 9.3 | 69 years STANDARD_DEVIATION 9.5 | 65 years STANDARD_DEVIATION 9 |
| Region of Enrollment United States | 8 participants | 8 participants | 16 participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 8 | 7 / 8 |
| serious Total, serious adverse events | 1 / 8 | 2 / 8 |
Outcome results
Primary
New Thrombosis, Amputation, Death, Major and Minor Bleeding
Time frame: 30 days
Population: All patients receiving drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Desirudin | New Thrombosis, Amputation, Death, Major and Minor Bleeding | 1 participants |
| Argatroban® | New Thrombosis, Amputation, Death, Major and Minor Bleeding | 5 participants |