Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia - Full Text View

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:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

MedlinePlus related topics: Deep Vein Thrombosis

Drug Information available for: Fondaparinux Fondaparinux sodium

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 2014
Estimated Primary Completion Date:	August 2014 (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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01727401

Contacts

Contact: Marcello Di Nisio, MD, PhD

0039 3283290020

mdinisio@unich.it

Locations

Italy
Marcello Di Nisio	Recruiting
Chieti, Italy, 66100
Contact: Marcello Di Nisio, MD, PhD 0039 328 3290020 mdinisio@unich.it
Principal Investigator: Ettore Porreca, MD

Sponsors and Collaborators

G. d'Annunzio University

Investigators

Study Chair:

Marcello Di Nisio, PhD

G. d'Annunzio University

More Information

No publications provided

Responsible Party:	Marcello Di Nisio, Principal Investigator, G. d'Annunzio University
ClinicalTrials.gov Identifier:	NCT01727401 History of Changes
Other Study ID Numbers:	213/2012
Study First Received:	November 8, 2012
Last Updated:	November 12, 2012
Health Authority:	Italy: Ethics Committee

Keywords provided by G. d'Annunzio University:

Fondaparinux
medical patient
vein thromboembolism
prophylaxis
thrombocytopenia

Additional relevant MeSH terms:

Blood Platelet Disorders
Thrombocytopenia
Thromboembolism
Venous Thrombosis
Venous Thromboembolism
Hematologic Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis

Fondaparinux
PENTA
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013

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