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

Pfizer102 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Acute Deep Vein Thrombosis

Interventions

Fragmin (dalteparin sodium )DRUG

Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg

Time frame: Month 6 or End of Treatment (EOT) (up to Month 6)

Secondary Outcomes

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

Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from gastrointestinal (GIT), urinary system or gynecological bleeding resulted in a need for a transfusion of at least 2 units of blood. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.

Time frame: Baseline through Month 6 or EOT (up to Month 6)

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

Episodes of the severe bleeding (intracranial, intraspinal, intraocular, retroperitoneal, or in pericardial area) or bleeding from GIT, urinary system or gynecological bleeding which led to a drop of hemoglobin of at least 2.0 g/dL. Subjects were assessed for severe bleeding as part of a systematic adverse event assessment.

Time frame: Baseline through Month 6 or EOT (up to Month 6)

Percent of Participants With and Without Pulmonary Embolism (PE)

PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)

Time frame: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)

Number of Participants With Recurrent DVT

Defined as the number of participants with recurrence of DVT (diagnosed using compressive ultrasound examination or autopsy) after it has resolved (at the same location) or occurrence of new DVT at a new location on any of the post-baseline visits

Data from ClinicalTrials.gov

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