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

NCT01727401 | Terminated Phase 4 DMC

• 1 other identifier: 213/2012
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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

Keywords

Fondaparinux; medical patient; vein thromboembolism; prophylaxis; thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Major bleeding

  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.

  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 (3)

• 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

• 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

• 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

Study Arms (1)

Fondaparinux

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

Drug: Fondaparinux

Interventions

Fondaparinux 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

Also known as: Arixtra

Fondaparinux

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• G. d'Annunzio University: lead

Study Sites (1)

Marcello Di Nisio

Chieti, 66100, Italy

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Fondaparinux

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

Oligosaccharides; Polysaccharides; Carbohydrates

Study Officials

• Marcello Di Nisio, PhD

  G. d'Annunzio University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 16, 2012
• Study Start: November 1, 2012
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 21, 2021

Record last verified: 2021-07

Locations

IT (1)