Overview

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

Status:
Completed
Trial end date:
2011-02-01
Target enrollment:
0
Participant gender:
All
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.
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pfizer
Treatments:
Dalteparin
Heparin, Low-Molecular-Weight
Tinzaparin
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.