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

Condition(s) targeted: Acute Deep Vein Thrombosis

Intervention: Fragmin (dalteparin sodium ) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

Official title: Fragmin Safety And Efficacy In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism And Extended Thromboprophylaxis In Cancer Patients In Slovakia (An Open, Prospective, Non-Comparative Study)

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg

Secondary outcome:

Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood

Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)

Percent of Participants With and Without Pulmonary Embolism (PE)

Number of Participants With Recurrent DVT

Detailed 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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

To obtain contact information for a study center near you, click here.

Starting date: June 2007
Last updated: July 14, 2010