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

Last updated on March 14, 2019

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Male or female patient, undergoing major orthopedic surgery

- At least 18 years old

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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.

NCT01046903
Pfizer
Completed
An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]

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