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

NCT00480636 | Completed Results

• 1 other identifier: A6301082
• Study Type: observational
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Deep Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Resolution of Deep Vein Thrombosis (DVT) of the Leg

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

  Month 6 or End of Treatment (EOT) (up to Month 6)

Secondary Outcomes (4)

• 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)

• 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)

• 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)

• Number of Participants With Recurrent DVT

  Month 6 or EOT (up to Month 6)

Study Arms (1)

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 )

Interventions

Fragmin (dalteparin sodium ) DRUG

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

Also known as: Fragmin

One cohort of patients treated with dalteparin.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients are identified in primary care setting.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Interventions

Dalteparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 29, 2007
• First Posted: May 31, 2007
• Study Start: June 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: August 10, 2010
• Results First Posted: August 10, 2010

Record last verified: 2010-07