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

Primary Purpose

Medical Patient, Thrombocytopenia

Status
Terminated
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Fondaparinux
Sponsored by
G. d'Annunzio University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Medical Patient focused on measuring Fondaparinux, medical patient, vein thromboembolism, prophylaxis, thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Marcello Di Nisio

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Fondaparinux

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Clinically relevant non-major bleeding
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
All bleeding events that cannot be classified as major or clinically relevant non-major
Symptomatic venous thromboembolism
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

Full Information

First Posted
November 8, 2012
Last Updated
July 14, 2021
Sponsor
G. d'Annunzio University
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1. Study Identification

Unique Protocol Identification Number
NCT01727401
Brief Title
Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia
Acronym
FAITH
Official Title
Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment rate
Study Start Date
November 2012 (Actual)
Primary Completion Date
July 2021 (Actual)
Study Completion Date
July 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
G. d'Annunzio University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Medical Patient, Thrombocytopenia
Keywords
Fondaparinux, medical patient, vein thromboembolism, prophylaxis, thrombocytopenia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fondaparinux
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Fondaparinux
Other Intervention Name(s)
Arixtra
Intervention Description
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 Outcome Measure Information:
Title
Major bleeding
Description
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.
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 Outcome Measure Information:
Title
Clinically relevant non-major bleeding
Description
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.
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
Title
Minor Bleeding
Description
All bleeding events that cannot be classified as major or clinically relevant non-major
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
Title
Symptomatic venous thromboembolism
Description
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcello Di Nisio, PhD
Organizational Affiliation
G. d'Annunzio University
Official's Role
Study Chair
Facility Information:
Facility Name
Marcello Di Nisio
City
Chieti
ZIP/Postal Code
66100
Country
Italy

12. IPD Sharing Statement

Learn more about this trial

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

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