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

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

Detailed Description
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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.

Official Title
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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)

Conditions
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Acute Deep Vein Thrombosis

Intervention / Treatment
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* Drug: Fragmin (dalteparin sodium )


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| One cohort of patients treated with dalteparin.<br>About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study. | Drug: Fragmin (dalteparin sodium )<br>* Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.<br>* Other names: Fragmin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Month 6 or End of Treatment (EOT) (up to Month 6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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) | 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 | Month 6 or EOT (up to Month 6) |