Phase 2
N=20
Clinical Management of Argatroban in Patients With Heparin Induced Thrombocytopenia Type II
Heparin-induced Thrombocytopenia Type II
Bottom Line
View on ClinicalTrials.gov: NCT00861692 ↗Enrolled (actual)
20
Serious AEs
70.0%
Results posted
Dec 2015
Primary outcome: Primary: Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation — 10 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- argatroban (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Tanabe Pharma Corporation
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of All-cause Death, Thrombosis (New and Extended) and Unplanned Amputation |
10 | — |
| PRIMARY All-cause Death |
6 | — |
| PRIMARY Death Related to Heparin-induced Thrombocytopenia (HIT) |
— | — |
| PRIMARY Number of Patients With Thrombosis (New and Extended) |
5 | — |
| PRIMARY Number of Patients With Unplanned Amputation |
— | — |
| PRIMARY Number of Patients With Major or Minor Bleeding |
4 | — |
| PRIMARY Number of Patients With Platelet Count Recovery |
12 | — |
Summary
The purpose of this study is to collect data on the clinical management of Argatroban in patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral antithrombotic therapy
Eligibility Criteria
Inclusion Criteria
- Subjects aged >= 18 years
- Females of child bearing potential must have a negative urine pregnancy test prior to entry into the study
- Patients with suspected or confirmed heparin-induced thrombocytopenia Type II, with or without ongoing thrombosis who require parenteral anticoagulation
- Signed written informed consent by the subject, or if the subject is unable to do so, consent will be sought from their family member, or a trusted person nominated by the subject or the legal representative
Exclusion Criteria
- Uncontrolled bleeding
- Severe hepatic impairment (Child-Pugh Class C)
- Hypersensitivity to argatroban or to any of the excipients (sorbitol and ethanol)
- Pregnancy (exclusion by routine urine test)
- Lactating woman
Data sourced from ClinicalTrials.gov (NCT00861692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.