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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00480636
First received: May 29, 2007
Last updated: July 14, 2010
Last verified: July 2010

May 29, 2007
July 14, 2010
June 2007
June 2009   (final data collection date for primary outcome measure)
Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg [ Time Frame: Month 6 or End of Treatment (EOT) (up to Month 6) ] [ Designated as safety issue: No ]
Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg
Not Provided
Complete list of historical versions of study NCT00480636 on ClinicalTrials.gov Archive Site
  • Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood [ Time Frame: Baseline through Month 6 or EOT (up to Month 6) ] [ Designated as safety issue: Yes ]
    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.
  • Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL) [ Time Frame: Baseline through Month 6 or EOT (up to Month 6) ] [ Designated as safety issue: Yes ]
    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.
  • Percent of Participants With and Without Pulmonary Embolism (PE) [ Time Frame: Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6) ] [ Designated as safety issue: No ]
    PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)
  • Number of Participants With Recurrent DVT [ Time Frame: Month 6 or EOT (up to Month 6) ] [ Designated as safety issue: No ]
    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
Not Provided
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

The patients are identified in primary care setting.

Acute Deep Vein Thrombosis
Drug: Fragmin (dalteparin sodium )
Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.
Other Name: Fragmin
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.
Intervention: Drug: Fragmin (dalteparin sodium )
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
102
June 2009
June 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00480636
A6301082
No
Director, Clinical Trial Disclosure Group, Pfizer Inc
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP