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

NCT ID: NCT01046903

Last Updated: 2012-02-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 503 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2011-02-28

Brief 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.

Detailed Description

All patients prescribed Fragmin® (Dalteparin Sodium) for prolonged thromboprophylaxis will be eligible for study

Conditions

Venous Thromboembolism

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Fragmin® (Dalteparin Sodium)

Intervention Type: DRUG

Administered per prescribing physician

Interventions

Fragmin® (Dalteparin Sodium)

Administered per prescribing physician

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Related Links

https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6301085&StudyName=An%20Observational%20Study%20On%20The%20Safety%20And%20Tolerability%20Of%20Prolonged%20Thrombosis%20Prophylaxis%20With%20Fragmin%AE%20

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Other Identifiers

A6301085

Identifier Type: -

Identifier Source: org_study_id