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

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: Fragmin® (Dalteparin Sodium)

• Registration Number: NCT01046903
• Lead Sponsor: Pfizer

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

Study Timeline

• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Study Start: 2010-03
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Results First Submitted: 2012-01-03
• Results First Submitted QC: 2012-01-03
• Status Verified: 2012-02
• Results First Posted: 2012-02-13
• Last Update Submitted: 2012-02-24
• Last Update Posted: 2012-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 503

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Fragmin® (Dalteparin Sodium)	-

Primary Outcome Measures

Name	Time	Method
Physician's Assessment of Efficacy of Treatment	Baseline up to Week 5	Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.