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

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)

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

Study Overview

• Status: Completed
• Conditions: Acute Deep Vein Thrombosis
• Intervention / Treatment: Drug: Fragmin (dalteparin sodium )

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.

• Study Type: Observational
• Enrollment (Actual): 102

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The patients are identified in primary care setting.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2007
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: May 29, 2007
• First Submitted That Met QC Criteria: May 29, 2007
• First Posted (Estimate): May 31, 2007

Study Record Updates

• Last Update Posted (Estimate): August 10, 2010
• Last Update Submitted That Met QC Criteria: July 14, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Thrombosis; Venous Thrombosis; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: A6301082