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Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia (FAITH)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01727401
First Posted: November 16, 2012
Last Update Posted: December 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcello Di Nisio, G. d'Annunzio University
  Purpose
Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous thromboembolism in high risk medical patients. A relevant proportion of these patients have renal insufficiency and/or thrombocytopenia which represent independent risk factors for bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg daily, has been approved for patients with renal insufficiency defined by a creatinine clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate the safety of fondaparinux in high risk hospitalized medical patients with a moderate to severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.

Condition Intervention Phase
Medical Patient Thrombocytopenia Drug: Fondaparinux Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia

Resource links provided by NLM:


Further study details as provided by Marcello Di Nisio, G. d'Annunzio University:

Primary Outcome Measures:
  • Major bleeding [ Time Frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks ]
    Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death.


Secondary Outcome Measures:
  • Clinically relevant non-major bleeding [ Time Frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks ]
    clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life.

  • Minor Bleeding [ Time Frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks ]
    All bleeding events that cannot be classified as major or clinically relevant non-major

  • Symptomatic venous thromboembolism [ Time Frame: Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks ]
    Deep vein thrombosis will be confirmed by compression ultrasonography or venography. Pulmonary embolism will be confirmed by spiral computed tomography or V/Q lung scan


Estimated Enrollment: 117
Study Start Date: November 2012
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fondaparinux
Drug: fondaparinux once daily sc injections 2.5 mg if renal clearance of creatinine above 50 ml/min once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min
Drug: Fondaparinux
Fondaparinux once daily sc injections at a dose of 2.5 mg if renal clearance of creatinine above 50 ml/min or Fondaparinux once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min
Other Name: Arixtra

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age above 18 years;
  • hospitalization in an Internal Medicine Unit and a Barbar score of 4 points or above
  • Platelet count between 100,000/uL and 30,000/uL
  • written informed consent

Exclusion Criteria:

  • Active bleeding or bleeding within the previous 3 months;
  • Known bleeding diathesis;
  • Active gastroduodenal ulcer;
  • Severe renal insufficiency defined by a creatinine clearance below 20 mL/min;
  • Ongoing treatment with unfractionated heparin, low-moleculr-weight heparin, fondaparinux, or oral anticoagulants Trattamento in corso con eparina non
  • Prophylaxis with unfractionated heparin, low-moleculr-weight heparin, or fondaparinux for more than 48 hours;
  • double antiplatelet therapy or acetylsalicylic acid at daily doses above 165 mg;
  • planned invasive procedure during the period of thromboprophylaxis;
  • Hemoglobin values below 9 g/dL;
  • AST or ALT above 2 times the uper limit of normal;
  • pregnancy or breast feeding;
  • life expectancy lower than 1 month
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01727401


Locations
Italy
Marcello Di Nisio
Chieti, Italy, 66100
Sponsors and Collaborators
G. d'Annunzio University
Investigators
Study Chair: Marcello Di Nisio, PhD G. d'Annunzio University
  More Information

Responsible Party: Marcello Di Nisio, Principal Investigator, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT01727401     History of Changes
Other Study ID Numbers: 213/2012
First Submitted: November 8, 2012
First Posted: November 16, 2012
Last Update Posted: December 5, 2016
Last Verified: May 2016

Keywords provided by Marcello Di Nisio, G. d'Annunzio University:
Fondaparinux
medical patient
vein thromboembolism
prophylaxis
thrombocytopenia

Additional relevant MeSH terms:
Thromboembolism
Thrombocytopenia
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Blood Platelet Disorders
Hematologic Diseases
Fondaparinux
PENTA
Factor Xa Inhibitors
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents