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
  Purpose

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


Condition Intervention
Acute Deep Vein Thrombosis
Drug: Fragmin (dalteparin sodium )

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome 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) ] [ Designated as safety issue: No ]
    Resolution criteria: clinical cure, defined as negative results of a compressive ultrasound examination of the leg


Secondary Outcome 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) ] [ 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


Enrollment: 102
Study Start Date: June 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The patients are identified in primary care setting.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480636

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer Inc
ClinicalTrials.gov Identifier: NCT00480636     History of Changes
Other Study ID Numbers: A6301082
Study First Received: May 29, 2007
Results First Received: May 25, 2010
Last Updated: July 14, 2010
Health Authority: Slovakia: State Institute for Drug Control

Additional relevant MeSH terms:
Pulmonary Embolism
Thrombosis
Venous Thrombosis
Cardiovascular Diseases
Embolism
Embolism and Thrombosis
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Dalteparin
Heparin, Low-Molecular-Weight
Anticoagulants
Cardiovascular Agents
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014