An Observational Study On The Safety And Tolerability Of Prolonged Thrombosis Prophylaxis With Fragmin®
NCT01046903
ABOUT THIS STUDY
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- Male or female patient, undergoing major orthopedic surgery
- At least 18 years old
- 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.
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Descriptive Information | ||||
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Brief Title | 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 | |||
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 Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | The adult population (women and men) after major orthopedic surgery. | |||
Condition | Venous Thromboembolism | |||
Intervention | Drug: Fragmin® (Dalteparin Sodium)
Administered per prescribing physician | |||
Study Groups/Cohorts | 1
Intervention: Drug: Fragmin® (Dalteparin Sodium) | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 503 | |||
Original Estimated Enrollment | 600 | |||
Actual Study Completion Date | February 2011 | |||
Actual Primary Completion Date | February 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Not Provided | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01046903 | |||
Other Study ID Numbers | A6301085 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2012 |