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

NCT ID: NCT00480636

Last Updated: 2010-08-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-06-30

Study Completion Date

2009-06-30

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.

Conditions

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Acute Deep Vein Thrombosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Fragmin (dalteparin sodium )

Intervention Type DRUG

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

Interventions

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Fragmin (dalteparin sodium )

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

Intervention Type DRUG

Other Intervention Names

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Fragmin

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Pfizer Inc

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

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Other Identifiers

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A6301082

Identifier Type: -

Identifier Source: org_study_id

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