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

Primary Purpose

Heparin-induced Thrombocytopenia

Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Warfarin, NOAC
Sponsored by
Marshall University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heparin-induced Thrombocytopenia

Eligibility Criteria

18 Years - 97 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marshall UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1 month

3 months

Arm Description

patient treated with Anti coagulation for one month

standard of care , treatment for 3 months

Outcomes

Primary Outcome Measures

All cause hospitalization
side effects of Warfarin treatment
All cause mortality

Secondary Outcome Measures

Full Information

First Posted
May 1, 2017
Last Updated
August 14, 2018
Sponsor
Marshall University
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1. Study Identification

Unique Protocol Identification Number
NCT03147638
Brief Title
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
Acronym
HIT
Official Title
Multi-Center Single Arm Trial to Determine The Effectiveness of Warfarin Therapy Duration For Heparin-Induced Thrombocytopenia (HIT)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 11, 2017 (Actual)
Primary Completion Date
January 11, 2019 (Anticipated)
Study Completion Date
June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marshall University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heparin-induced Thrombocytopenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
Single arm with retrospective arm The retrospective arm is he comparator and they are historic control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 month
Arm Type
Experimental
Arm Description
patient treated with Anti coagulation for one month
Arm Title
3 months
Arm Type
Active Comparator
Arm Description
standard of care , treatment for 3 months
Intervention Type
Drug
Intervention Name(s)
Warfarin, NOAC
Intervention Description
duration of treatment
Primary Outcome Measure Information:
Title
All cause hospitalization
Time Frame
Within six months after treatment
Title
side effects of Warfarin treatment
Time Frame
Within six months after treatment
Title
All cause mortality
Time Frame
Within six months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
97 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yazan Numan, M.D.
Phone
3045910000
Email
numan@marshall.edu
Facility Information:
Facility Name
Marshall University
City
Huntington
State/Province
West Virginia
ZIP/Postal Code
25701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yazan Numan, M.D.
Phone
304-591-0000
Email
numan@marshall.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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