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

NCT03147638 | Unknown Phase 3 DMC FDA Drug

• 1 other identifier: 943871-5
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Heparin-induced Thrombocytopenia

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

1 month

EXPERIMENTAL

patient treated with Anti coagulation for one month

Drug: Warfarin, NOAC

3 months

ACTIVE COMPARATOR

standard of care , treatment for 3 months

Drug: Warfarin, NOAC

Interventions

Warfarin, NOAC DRUG

duration of treatment

1 month; 3 months

Eligibility Criteria

• Age: 18 Years - 97 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Marshall University: lead

Study Sites (1)

Marshall University

Huntington, West Virginia, 25701, United States

RECRUITING

MeSH Terms

Interventions

Warfarin; N(4)-oleylcytosine arabinoside

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yazan Numan, M.D.

CONTACT

3045910000; numan@marshall.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: Single arm with retrospective arm The retrospective arm is he comparator and they are historic control

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 10, 2017
• Study Start: January 11, 2017
• Primary Completion: January 11, 2019
• Study Completion: June 30, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)