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

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Marshall University
• Treatments: Heparin; Warfarin

Criteria

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