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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Deep Vein Thrombosis

Intervention: Fragmin (dalteparin sodium ) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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)

Study design: Observational Model: Cohort, Time Perspective: Prospective

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

Secondary outcome:

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

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

Percent of Participants With and Without Pulmonary Embolism (PE)

Number of Participants With Recurrent DVT

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

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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 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.

Locations and Contacts

Additional Information

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

Starting date: June 2007
Last updated: July 14, 2010

Page last updated: August 20, 2015

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