Overview

This trial is active, not recruiting.

Conditions medical patient, thrombocytopenia
Treatment fondaparinux
Phase phase 4
Sponsor G. d'Annunzio University
Start date November 2012
End date August 2016
Trial size 117 participants
Trial identifier NCT01727401, 213/2012

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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
fondaparinux Arixtra
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

Primary Outcomes

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

Secondary Outcomes

Measure
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
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
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by G. d'Annunzio University.