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

Acute Deep Vein Thrombosis Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00480636
• Other study ID #: A6301082
• Status: Completed
• Phase: N/A
• First received: May 29, 2007
• Last updated: July 14, 2010
• Start date: June 2007
• Est. completion date: June 2009

Study information

• Verified date: July 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Slovakia: State Institute for Drug Control
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Deep Vein Thrombosis
• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Fragmin (dalteparin sodium )
Month 1: dalteparin 200 IU/kg SC once daily. Months 2-6: dalteparin 150 IU/kg SC, once daily.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Number of Participants With Severe Bleeding That Resulted in a Transfusion of at Least 2 Units of Blood	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.	Baseline through Month 6 or EOT (up to Month 6)	Yes
Secondary	Number of Participants With Severe Bleeding That Resulted in a Decrease in Hemoglobin Level of at Least 2.0 Grams Per Deciliter (g/dL)	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.	Baseline through Month 6 or EOT (up to Month 6)	Yes
Secondary	Percent of Participants With and Without Pulmonary Embolism (PE)	PE (diagnosed on the basis of ventilation-perfusion scan of the lungs or autopsy)	Baseline, Week 2, Month 1, Month 3, and Month 6 or EOT (up to Month 6)	No
Secondary	Number of Participants With Recurrent DVT	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	Month 6 or EOT (up to Month 6)	No

External Links

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