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

NCT ID: NCT03147638

Last Updated: 2018-08-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-11
• Study Completion Date: 2019-06-30

Brief Summary

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

Conditions

Heparin-induced Thrombocytopenia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 month

patient treated with Anti coagulation for one month

Group Type: EXPERIMENTAL

Warfarin, NOAC

Intervention Type: DRUG

duration of treatment

3 months

standard of care , treatment for 3 months

Group Type: ACTIVE_COMPARATOR

Warfarin, NOAC

Intervention Type: DRUG

duration of treatment

Interventions

Warfarin, NOAC

duration of treatment

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 97 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marshall University

OTHER

Sponsor Role: lead

Responsible Party

Yazan Numan

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Marshall University

Huntington, West Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yazan Numan, M.D.

Role: CONTACT

numan@marshall.edu

3045910000

Facility Contacts

Yazan Numan, M.D.

Role: primary

numan@marshall.edu

304-591-0000

Other Identifiers

943871-5

Identifier Type: -

Identifier Source: org_study_id