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

August 14, 2018 updated by: Yazan Numan, Marshall University
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Huntington, West Virginia, United States, 25701
        • Recruiting
        • Marshall University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marshall University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2017

Primary Completion (Anticipated)

January 11, 2019

Study Completion (Anticipated)

June 30, 2019

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 9, 2017

First Posted (Actual)

May 10, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 943871-5

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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