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)
18 Years
70 Years
Both
Acute Deep Vein Thrombosis
Trial Information
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)
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg
Outcome Description:
Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
Outcome Time Frame:
Month 6 or End of Treatment (EOT) (up to Month 6)
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Slovakia: State Institute for Drug Control
Study ID:
A6301082
NCT ID:
NCT00480636
Start Date:
June 2007
Completion Date:
June 2009
Related Keywords:
- Acute Deep Vein Thrombosis
- Embolism
- Pulmonary Embolism
- Thrombosis
- Venous Thrombosis
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