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

Heparin-induced Thrombocytopenia Clinical Trial

— HIT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03147638
• Other study ID #: 943871-5
• Status: Recruiting
• Phase: Phase 3
• Start date: January 11, 2017
• Est. completion date: June 30, 2019

Study information

• Verified date: August 2018
• Source: Marshall University
• Contact: Yazan Numan, M.D.
• Phone: 3045910000
• Email: numan[@]marshall.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 30, 2019
• Est. primary completion date: January 11, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 97 Years

Eligibility

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

Related Conditions & MeSH terms

• Heparin-induced Thrombocytopenia
• Thrombocytopenia

Intervention

Drug:
• Warfarin, NOAC
duration of treatment

Locations

Country	Name	City	State
United States	Marshall University	Huntington	West Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Marshall University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause hospitalization		Within six months after treatment
Primary	side effects of Warfarin treatment		Within six months after treatment
Primary	All cause mortality		Within six months after treatment