Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)

Study Overview
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Brief Summary
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Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)

Official Title
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Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)

Conditions
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Heparin-induced Thrombocytopenia

Intervention / Treatment
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* Drug: Warfarin, NOAC


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 97 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Single arm with retrospective arm The retrospective arm is he comparator and they are historic control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 month<br>patient treated with Anti coagulation for one month | Drug: Warfarin, NOAC<br>* duration of treatment<br>|
| Active Comparator: 3 months<br>standard of care , treatment for 3 months | Drug: Warfarin, NOAC<br>* duration of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause hospitalization |  | Within six months after treatment | 
| side effects of Warfarin treatment |  | Within six months after treatment | 
| All cause mortality |  | Within six months after treatment |