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

NCT ID: NCT01727401

Last Updated: 2021-07-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2021-07-31

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.

Conditions

Medical Patient; Thrombocytopenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fondaparinux

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Arixtra

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

G. d'Annunzio University

OTHER

Sponsor Role: lead

Responsible Party

Marcello Di Nisio

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcello Di Nisio, PhD

Role: STUDY_CHAIR

G. d'Annunzio University

Locations

Marcello Di Nisio

Chieti, , Italy

Countries

Italy

Other Identifiers

213/2012

Identifier Type: -

Identifier Source: org_study_id