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Fondaparinux vs Lepirudin in the treatment of heparin-induced thrombocytopenia, with or without thrombosis. A multicenter, randomized, parallel group study of treatment with fondaparinux (7.5 mg s.c. once daily) versus aPTT-adjusted Lepirudin infusion (0,15 or 0,10 mg/Kg/hr) in the management of patients with heparin-induced thrombocytopenia with or without thrombosis. - ND

Fondaparinux vs Lepirudin in the treatment of heparin-induced thrombocytopenia, with or without thrombosis. A multicenter, randomized, parallel group study of treatment with fondaparinux (7.5 mg s.c. once daily) versus aPTT-adjusted Lepirudin infusion (0,15 or 0,10 mg/Kg/hr) in the management of patients with heparin-induced thrombocytopenia with or without thrombosis. - ND

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-000564-25-IT
Enrollment
Unknown
Registered
2007-05-24
Start date
2007-04-04
Completion date
Unknown
Last updated
2012-04-18

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

Conditions

thrombocytopenia heparin-induced MedDRA version: 9.1 Level: LLT Classification code 10062506 Term: Heparin-induced thrombocytopenia

Interventions

Trade Name: ARIXTRA Pharmaceutical Form: Solution for injection INN or Proposed INN: Fondaparinux Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 7.5- Trade Name:

Sponsors

OSPEDALE POLICLINICO S. MATTEO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: heparin-induced thrombocytopenia with o r without thromboelbolic complications; positivity of heparin/PF4 IgG antibodies, age 18 years or over; written informed 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: treatment with any other investigational drug within 7 days before study entry; alcohol or drug abuse, overt signs of bleeding, known hypersensitivity to hirudin, lepirudin or fondaparinux, pregnancy, anticipated poor compliance, renal failure.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: not specified;Primary end point(s): cumulative incidence of new clinically manifest thromboembolic complications, amputations and death.;Main Objective: to investigate efficacy and safety of once-daily fondaparinux treatment in subjects with heparin-induced thrombocytopenia with o r without thromboembolic complications, using lepirudin as a comparator.—

Countries

Italy

Outcome results

None listed

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