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An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®

Information source: Pfizer
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Venous Thromboembolism

Intervention: Fragmin® (Dalteparin Sodium) (Drug)

Phase: N/A

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

The objective of this study is to observe the safety, tolerability, and compliance in the use of Fragmin for prolonged thromboprophylaxis in post-surgery high-risk orthopedic patients.

Clinical Details

Official title: An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Physician's Assessment of Efficacy of Treatment

Detailed description: All patients prescribed Fragmin (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or female patient, undergoing major orthopedic surgery

- At least 18 years old

Exclusion Criteria:

- Hypersensitivity to Fragmin or other low molecular weight heparins or unfractioned

heparin;

- History of heparin induced thrombocytopaenia type II

- Acute gastroduodenal ulcer, cerebral haemorrhage, or other active haemorrhage.

- Serious coagulation disorder;

- Septic endocarditis;

- Injuries to and operations in the central nervous system, eye and ear within one

month before orthopaedic surgery;

- Spinal or epidural anesthesia or other procedures requiring spinal puncture and

concomitant treatment with high doses of dalteparin (such as those needed to treat acute deep vein thrombosis, pulmonary embolism, and Unstable coronary artery disease);

- Patients with serum creatinine level > 150 umol/l;

- Platelet count of less than 100 000 per cubic millimeter at the beginning of the

therapy;

- High probability that patient will not return to the centre for follow-up;

- Patient on oral anticoagulation therapy in the last 7 days;

- Ongoing anticoagulant therapy with other medications or non-pharmacologic therapy

during the study period;

- Weight less than 40 kg;

- Simultaneous participation in another pharmacological study or receiving any

investigational drug 30 days or less before surgery;

- Pregnancy or breastfeeding;

- Clinically significant hepatic dysfunction.

Locations and Contacts

Additional Information

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

Starting date: March 2010
Last updated: February 24, 2012

Page last updated: August 20, 2015

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