Clinical trial NCT01046903: An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
Official title: An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin® (Dalteparin Sodium) In Patients Undergoing Major Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Thromboembolism
Keywords: observational prolonged thromboprophylaxis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 503
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The adult population (women and men) after major orthopedic surgery.

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

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.

Primary outcomes:
measure: Physician's Assessment of Efficacy of Treatment
timeFrame: Baseline up to Week 5
Secondary outcomes:
Other outcomes:
measure: Participant's Dosage Regimen
timeFrame: Baseline up to Week 5
measure: Number of Participants With Risk Factors
timeFrame: Baseline
measure: Number of Participants With Thromboembolism
timeFrame: Baseline up to Week 5
measure: Number of Participants With Bleeding
timeFrame: Baseline up to Week 5
measure: Participant's Global Evaluation of Treatment
timeFrame: Baseline up to Week 5
measure: Physician's Assessment of Tolerability of Treatment
timeFrame: Baseline up to Week 5
measure: Administration Schedule of Treatment
timeFrame: Baseline up to Week 5
measure: Number of Participants Compliant With the Treatment
timeFrame: Baseline up to Week 5
measure: Number of Participants With Hematoma
timeFrame: Baseline up to Week 5
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: