Fondaparinux for the Treatment of Heparin-Induced Thrombocytopenia (HIT)

NCT00673439 | Terminated Phase 2 Results DMC

• 2 other identifiers: 07.0100BCC-NON-07-001
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how safe and effective fondaparinux is in treating patients with suspected or confirmed heparin-induced thrombocytopenia (HIT).

Conditions

Heparin-Induced Thrombocytopenia

Keywords

heparin-induced thrombocytopenia; thrombocytopenia; HIT; thrombosis; blood clot; blood thinner; anticoagulant; heparin; warfarin; fondaparinux; Arixtra

Outcome Measures

Primary Outcomes (1)

• Number of Participants Showing Clinically Significant Bleeding

  Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux

  4 weeks after INR reaches 2 or more

Secondary Outcomes (1)

• the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux

  4 weeks after INR reaches 2 or more

Study Arms (1)

Fondaparinux

EXPERIMENTAL

daily subcutaneous injection of fondaparinux (7.5-10 mg)

Drug: fondaparinux; Drug: warfarin

Interventions

fondaparinux DRUG

Dosage form: subcutaneous injection; dosage: 7.5 to 10.0 mg; frequency and duration: daily until blood test results rule out confirmed HIT - for patients with confirmed HIT, continue daily until INR (blood clotting) measurement rises to at least 2

Also known as: Arixtra

Fondaparinux

warfarin DRUG

Dosage form: oral; dosage: 2.5 to 5.0 mg; frequency and duration: (for confirmed HIT only) once daily, to begin when blood platelet count reaches at least 100,000, and continue for approximately 4 weeks

Also known as: Coumadin

Fondaparinux

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• high risk for HIT based on "Four Ts score" of 6 or more

You may not qualify if:

• pulmonary emboli at the time of enrollment
• arterial thrombosis at the time of enrollment
• limb threatening phlegmasia cerulea dolens at the time of enrollment
• Calculated Creatinin Clearance less than 50 ml/hr
• platelet count less than 50
• Weight less than 50 kg
• pregnancy
• allergy to fondaparinux
• bacterial endocarditis
• history of neuraxial anesthesia and post-operative indwelling epidural catheter
• active major bleeding (hemodynamically significant or requiring transfusions)
• inability to give informed consent

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Thrombocytopenia; Thrombosis

Interventions

Fondaparinux; Warfarin

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Limitations and Caveats

Study terminated, results data not available

Results Point of Contact

• Title: Goetz H Kloecker, MD, MSPH
• Organization: James Graham Brown Cancer Center

ghkloe01@exchange.edu

502/562-4358

Study Officials

• Goetz H Kloecker, MD, MSPH

  James Graham Brown Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: November 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 8, 2019
• Results First Posted: June 24, 2013

Record last verified: 2019-10

Locations

US (1)