Prevention of venous thrombosis in cancer patients: A prospective, randomized, double-blind study comparing two different dosages of low-molecular weight heparin

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002068-27-AT

Enrollment

Registered

2006-03-16

Start date

2006-04-20

Completion date

Unknown

Last updated

2016-06-20

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

Conditions

cancer patients

Interventions

Trade Name: Lovenox Product Name: Lovenox Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients (> 18 years) with active cancer and at least one of the following indications for thromboprophylaxis with LMWH: • immobilization • history of VTE • acute inflammation • heart failure • respiratory failure 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: • indication for LMWH or UFH at therapeutic dosages (e.g. for acute venous thromboembolism) • treatment with antithrombotics (vitamin K antagonists, acetylsalicylic acid, clopidogrel) for reasons other than prevention of VTE (e.g. atrial fibrillation, myocardial infarction) • contraindication for the treatment with LMWH • surgery within the last 4 weeks • thrombocytopenia ( 100 kg • renal insufficiency (creatinine ? 2 mg/dl)

Design outcomes

Primary

Measure	Time frame
Main Objective: to investigate the effect of LMWH on hemostatic system activation, as measured by the levels of F1+2 and D-dimer, in cancer patients to compare the effects of two different dosages of enoxaparin (40 mg od sc and 80 mg od sc) on these markers of hemostatic system activation in cancer patients ;Secondary Objective: to investigate the effects of these two different regimens of enoxaparin on the generation and composition of MPs in cancer patients;Primary end point(s):	—

Measure

Time frame

Main Objective: to investigate the effect of LMWH on hemostatic system activation, as measured by the levels of F1+2 and D-dimer, in cancer patients to compare the effects of two different dosages of enoxaparin (40 mg od sc and 80 mg od sc) on these markers of hemostatic system activation in cancer patients ;Secondary Objective: to investigate the effects of these two different regimens of enoxaparin on the generation and composition of MPs in cancer patients;Primary end point(s):

—

Countries

Austria

Outcome results

None listed

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