Recruiting
Phase 3

Warfarin

Sponsor:

Marshall University

Code:

NCT03147638

Conditions

Heparin-induced Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Warfarin, NOAC

Study Details

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 ID

NCT03147638

Start date

Jan 11, 2017

Status verified date

Aug, 2018

Completion date

Jun 30, 2019

Anticipated

Primary completion date

Jan 11, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

70 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1 month

patient treated with Anti coagulation for one month

active comparator: 3 months

standard of care , treatment for 3 months

Interventions

Warfarin, NOAC

duration of treatment

Primary outcome measure

  • All cause hospitalization [ Time Frame: Within six months after treatment ]
  • side effects of Warfarin treatment [ Time Frame: Within six months after treatment ]
  • All cause mortality [ Time Frame: Within six months after treatment ]

Central Contacts and Locations

Central contacts

Locations

Marshall University

Recruiting

Huntington, West Virginia, United States, 25701

Contacts

More Information

Sponsor

Marshall University

Last update posted

Aug 15, 2018

Last verified

Aug, 2018

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Marshall University on 2018-08-15.