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

Overview

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

Full Title of Study: “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 Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2009

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.

Interventions

  • Drug: Fragmin (dalteparin sodium )
    • Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
    • Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg

Secondary Measures

  • 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)
    • 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)
    • 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)
    • 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)
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Director, Clinical Trial Disclosure Group, Pfizer Inc
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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