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Completed

NCT Number: NCT00480636

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

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

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Key information

Conditions

Acute Deep Vein Thrombosis

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fragmin (dalteparin sodium )

Drug

Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.

Other names: Fragmin

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study 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)

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
May 31, 2007
Registry last updated
Aug 10, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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