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

Sponsor

G. d'Annunzio University (Other)

Overall Status

Terminated

CT.gov ID

NCT01727401

Collaborator

(none)

Enrollment

Location

Arm

104

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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

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 :

Nov 1, 2012

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 1, 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 Names: Arixtra

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

Outcome Measures

Primary Outcome Measures

Major bleeding [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 [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 [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 [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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