Clinical trial NCT01727401: Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia
Official title: Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Medical Patient
Thrombocytopenia
Keywords: Fondaparinux
medical patient
vein thromboembolism
prophylaxis
thrombocytopenia
Lead sponsor: G. d'Annunzio University
Sponsor class: OTHER
First posted: 2012-11-16
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Major bleeding
timeFrame: 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
timeFrame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
measure: Minor Bleeding
timeFrame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
measure: Symptomatic venous thromboembolism
timeFrame: Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks
Other outcomes:
Locations:
city: Chieti
country: Italy
facility: Marcello Di Nisio
Study officials:
affiliation: G. d'Annunzio University
name: Marcello Di Nisio, PhD
role: STUDY_CHAIR
References: