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

Completed

• Conditions: Acute Deep Vein Thrombosis
• Interventions: Drug: Fragmin (dalteparin sodium )

• Registration Number: NCT00480636
• Lead Sponsor: Pfizer

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2007-05-29
• Study First Submitted QC: 2007-05-29
• Study First Posted: 2007-05-31
• Study Start: 2007-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2010-05-25
• Status Verified: 2010-07
• Results First Submitted QC: 2010-07-14
• Last Update Submitted: 2010-07-14
• Results First Posted: 2010-08-10
• Last Update Posted: 2010-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
One cohort of patients treated with dalteparin.	Fragmin (dalteparin sodium )	About 100 patients with deep-vein thrombosis and with or without pulmonary embolism will be included in the study.

Primary Outcome Measures

Name	Time	Method
Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg	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 Outcome Measures

Name	Time	Method
Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood	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)	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)	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	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