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

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.

Study Overview

• Status: Terminated
• Conditions: Thrombocytopenia; Medical Patient
• Intervention / Treatment: Drug: Fondaparinux

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 4

Contacts and Locations

Study Locations

• Italy
  • Chieti, Italy, 66100
    • Marcello Di Nisio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: Arixtra

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major bleeding	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.	Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinically relevant non-major bleeding	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.	Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Minor Bleeding	All bleeding events that cannot be classified as major or clinically relevant non-major	Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Symptomatic venous thromboembolism	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	Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks

Collaborators and Investigators

• Sponsor: G. d'Annunzio University
• Investigators: Study Chair: Marcello Di Nisio, PhD, G. d'Annunzio University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2012
• Primary Completion (ACTUAL): July 1, 2021
• Study Completion (ACTUAL): July 1, 2021

Study Registration Dates

• First Submitted: November 8, 2012
• First Submitted That Met QC Criteria: November 12, 2012
• First Posted (ESTIMATE): November 16, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: prophylaxis; thrombocytopenia; Fondaparinux; medical patient; vein thromboembolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hematologic Diseases; Embolism and Thrombosis; Blood Platelet Disorders; Thromboembolism; Thrombocytopenia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Fondaparinux; PENTA
• Other Study ID Numbers: 213/2012