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

• ClinicalTrials.gov Identifier: NCT01727401
• Recruitment Status: Terminated
• First Posted: November 16, 2012
• Last Update Posted: July 21, 2021
• Sponsor: G. d'Annunzio University
• Information provided by (Responsible Party): Marcello Di Nisio, G. d'Annunzio University

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Medical Patient; Thrombocytopenia	Drug: Fondaparinux	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• 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
• Actual Study Start Date: November 2012
• Actual Primary Completion Date: July 2021
• Actual Study Completion Date: July 2021

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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
3. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: 213/2012
• First Posted: November 16, 2012
• Last Update Posted: July 21, 2021
• Last Verified: July 2021

Keywords provided by Marcello Di Nisio, G. d'Annunzio University:

Fondaparinux; medical patient; vein thromboembolism; prophylaxis; thrombocytopenia

Additional relevant MeSH terms:

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