Fragmin In The Treatment Of Acute Deep-Vein Thrombosis With Or Without Pulmonary Embolism In Cancer Patients
This study has been completed.
Sponsor:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00480636
First received: May 29, 2007
Last updated: July 14, 2010
Last verified: July 2010
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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 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:
|
Embolism Pulmonary Embolism Thrombosis Venous Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Lung Diseases Respiratory Tract Diseases Dalteparin |
Heparin, Low-Molecular-Weight Anticoagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 19, 2013