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

Venous Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046903
• Other study ID #: A6301085
• Status: Completed
• Phase: N/A
• First received: January 4, 2010
• Last updated: February 24, 2012
• Start date: March 2010
• Est. completion date: February 2011

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 503
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Fragmin® (Dalteparin Sodium)
Administered per prescribing physician

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physician's Assessment of Efficacy of Treatment	Efficacy of treatment as assessed by physician was evaluated on the 5 point categorical scale: excellent, very good, good, fair, poor.	Baseline up to Week 5	No

External Links

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