Pharmacodynamics of Fondaparinux subcutaneous versus continuous intravenous infusion in critically ill patients with or without vasopressors.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-004911-79-BE

Enrollment

Registered

2007-10-29

Start date

2007-10-17

Completion date

Unknown

Last updated

2025-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboprophylaxis to critically ill patients hospitalized in ICU with or without vasopressors MedDRA version: 9.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis

Interventions

Trade Name: ARIXTRA Pharmaceutical Form: Solution for injection CAS Number: GSK576428 Other descriptive name: FONDAPARINUX SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Critically ill patient hospitalized in ICU with or without vasopressors - Age > 18 years - Consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - renal insufficiency ( Cr Clearance 2) - high risk of bleeding that contraindicate anticoagulant prophylaxis (intracerebral haemorrhage, gastro- intestinal bleeding, …) - severe thrombopenia ( < 30.000/µL) - acute endocarditis

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary endpoint is to demonstrate that continuous infusion of fondaparinux provides a better thromboprophylaxis (assessed by anti Xa activity) than subcutaneous administration.;Secondary Objective: (1) Plasma antifactor Xa activity at baseline (before drug administration) and at 3, 6, 12 and 24 hours after fundaparinux administration (even though clinical efficacy is not completely represented by FXa activity) will be measured. (2) Measurements of routine hemostasis parameters, thrombine- antithrombin complex (TAT), D- dimeres and thromboelastometry study (ROTEM) at 3, 6, 12 and 24 hours after drug administration (3) Safety : Patient follow-up until day 28 after randomization or until hospital discharge ;Primary end point(s):	—

Measure

Time frame

Main Objective: The primary endpoint is to demonstrate that continuous infusion of fondaparinux provides a better thromboprophylaxis (assessed by anti Xa activity) than subcutaneous administration.;Secondary Objective: (1) Plasma antifactor Xa activity at baseline (before drug administration) and at 3, 6, 12 and 24 hours after fundaparinux administration (even though clinical efficacy is not completely represented by FXa activity) will be measured. (2) Measurements of routine hemostasis parameters, thrombine- antithrombin complex (TAT), D- dimeres and thromboelastometry study (ROTEM) at 3, 6, 12 and 24 hours after drug administration (3) Safety : Patient follow-up until day 28 after randomization or until hospital discharge ;Primary end point(s):

—

Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026