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

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ClinicalTrials.gov Identifier: NCT01727401
Recruitment Status : Active, not recruiting
First Posted : November 16, 2012
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Marcello Di Nisio, G. d'Annunzio University

November 8, 2012
November 16, 2012
May 9, 2018
November 2012
December 2019   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01727401 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia
Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
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.
Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Medical Patient
  • Thrombocytopenia
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
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
Intervention: Drug: Fondaparinux
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
117
Same as current
December 2019
December 2019   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
 
NCT01727401
213/2012
Yes
Not Provided
Not Provided
Marcello Di Nisio, G. d'Annunzio University
G. d'Annunzio University
Not Provided
Study Chair: Marcello Di Nisio, PhD G. d'Annunzio University
G. d'Annunzio University
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP