Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients

Pfizer

Status: Completed

Conditions: Acute Deep Vein Thrombosis

Treatments: Drug: Fragmin (dalteparin sodium )

Study type: Observational

Funder types: Industry

Identifiers

NCT00480636

A6301082

Details and patient eligibility

About

To collect postmarketing data about Fragmin safety and efficacy in the treatment of deep vein thrombosis with or without pulmonary embolism in cancer patients.

Full description

Method: consecutive patient sampling. Patients were (are) included in the study in consecutive manner if they fulfilled the inclusion criteria and any of the exclusion criteria were not present.

Enrollment: 102 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patient of 18 - 70 years of age.
• Cancer patient with proven deep-vein thrombosis with or without pulmonary embolism confirmed by combination of clinical signs and symptoms, pulmonary hypertension on echocardiogram, X-ray examination of the lung and eventually perfusion/ventilation scan of the lung.

Exclusion criteria

• Bleeding
• Hypersensitivity to FRAGMIN® or other low-molecular weight heparins.
• Serum creatinine level > 150 umol/l.
• Platelet count of less than 100 000 per cubic millimeter at the beginning of the therapy.
• Patient on oral anticoagulation therapy in the last 7 days.

Trial design

102 participants in 1 patient group

One cohort of patients treated with dalteparin.

Description:

About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study.

Treatment:

Drug: Fragmin (dalteparin sodium )