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

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00480636

Purpose

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

Condition	Intervention	Phase
Venous Thrombosis	Drug: dalteparin sodium	Phase IV

MedlinePlus related topics: Cancer Deep Vein Thrombosis Pulmonary Embolism

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective
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)

Further study details as provided by Pfizer:

Primary Outcome Measures:

The rate of patients with the resolution of deep vein thrombosis of the leg (criteria: clinical cure, negative results of a compressive ultrasound examination of the leg [ Time Frame: end of the study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

the safety of the treatment with dalteparin (mainly the episodes of the severe bleeding ) resulted in a need for a transfusion of at least 2 units of blood or led to a drop of hemoglobin of at least 2.0g per deciliter. [ Time Frame: end of the study ] [ Designated as safety issue: Yes ]
The rate of recurrent deep-vein thrombosis or pulmonary embolism (diagnosed using compressive ultrasound examination or on the basis of ventilation-perfusion scan of the lungs or autopsy. [ Time Frame: end of the study ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	100
Study Start Date:	August 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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: dalteparin sodium Month 1 Dalteparin 200 IU/kg SC once daily. Months 2-6 Dalteparin 150 IU/kg SC, once daily.

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

The patients are identified in primary care setting.

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 ECHO, 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480636

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Responsible Party:	Pfizer Inc ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A6301082
Study First Received:	May 29, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00480636
Health Authority:	Slovakia: State Institute for Drug Control

Keywords provided by Pfizer:

deep vein thrombosis

Study placed in the following topic categories:

Embolism and Thrombosis
Pulmonary Embolism
Respiratory Tract Diseases
Dalteparin
Embolism

Lung Diseases
Vascular Diseases
Venous Thrombosis
Thrombosis

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009