Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
Status unconfirmed · Phase 3
Conditions studied: Heparin-induced Thrombocytopenia
In brief
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
Key facts
- Study ID
- NCT03147638
- Run by
- Marshall University
- People needed
- 70
- Starts
- 2017-01-11
- Expected to finish
- 2019-06-30
- Last updated by the study team
- 2018-08-15
Who can join
Age: 18 and older, up to 97. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient must be able to provide an informed consent
- Patient older than 18 years' old
- Patient with suspected diagnosis of HIT, need 2 of the following:
- have a fall in platelet count of > 30% from a baseline prior to heparin/LMWH Platelet factor 4 (PF4) ELISA positive Develop skin lesions secondary to subcutaneous heparin With T score more than 4 For those less than 4 we will use serotonin release assay-SRA
- Patient received the bridging therapy of non-heparin anticoagulant
- Patient is receiving the standard of care treatment for HIT
- Patient is willing to be followed up for by one of the physicians listed in the delegation log
- The Primary physician responsible for the patient is agreeing for the patient to participate
- Patients are not involved in a clinical trial for HIT management
You may not qualify if…
- Patient is unable to sign an informed consent
- Patient doesn't have a confirmed diagnosis of HIT
- Patient Does not have Pulmonary embolus
- Patient does is not on Warfarin for other indications
- Patient is a known case of hypercoagulable disorder
- Patient is not willing to come back for follow up
- Patient is critically ill or has a life expectancy of less than 3 months
- Pregnancy that is in First trimester.
- Multi-system organ failure or estimated survival of less than 30 days
- Uncontrolled hypertension defined as a blood pressure >180/110 mm Hg
Where it is running
- Marshall University — Huntington, West Virginia, United States (enrolling)
Full record on ClinicalTrials.gov
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