prevention of VTE in patients undergoing elective total hip replacement surgery MedDRA version: 8.1 Level: LLT Classification code 10049909
Conditions
Interventions
Product Name: Hexadecasaccharide
Product Code: SR123781A
Pharmaceutical Form: Solution for injection
INN or Proposed INN: NA
CAS Number: 232602-93-6
Current Sponsor code: SR123781A
Other descriptive n
Sponsors
sanofi-aventis recherche développement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age = 18 years Undergoing elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed = 6 months prior to study entry Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Related to study methodology o Pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization o Treatment with any investigational product or investigational device in the last 30 days prior to randomization o Current addictive disorders that could interfere with study participation o Known progressive malignant disease o Ischemic stroke, myocardial infarction, any major orthopedic surgeryin the last 3 months o Clinical signs or symptoms of DVT or PE within the last 12 months or symptoms of post phlebitic syndrome o Treatment with other antithrombotic agents within 7 days prior to surgery o Serum creatinine > 2 mg/dL (180 µmol/L) in a well hydrated patient o Significant anemia (Hb < 10 g/dL) o Known sensitivity to iodine or contrast dyes o Use of any contraindicated drug that cannot be combined with the injection of contrast medium, e.g. antihyperglycemic drug metformin Related to the active calibrator o Any contra-indication or history of hypersensitivity to UFH or LMWH o Past or present bleeding disorder o Active or recent (<3 months) significant bleeding, including gastrointestinal bleeding or peptic ulcer o Uncontrolled arterial hypertension o Any history of hemorrhagic stroke o Known structural damage or other pathologic process involving the central nervous system o Recent (<3 months) trauma, major surgery, ophthalmic surgery or parenchymal organ biopsy o Thrombocytopenia o History of heparin induced thrombocytopenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the efficacy of SR123781A in the prevention of Venous Thromboembolism (DVTand/or PE) via demonstration of a dose-response in patients undergoing total hip replacement surgery;Secondary Objective: To evaluate the safety (incidence of major bleeding) of SR123781A in the prevention of VTE after elective total hip replacement surgery To assess the SR123781 pharmacokinetic profile in patients undergoing elective total hip replacement surgery;Primary end point(s): The primary efficacy endpoint is a composite of the following VTE outcome events: • Any DVT identified on mandatory venography of the lower limbs performed between day 5 and day 11 • Confirmed DVT and/or non-fatal PE in case of symptoms earlier than the date of the mandatory venography • VTE related deaths (Fatal PE and unexplained death) before the mandatory examination | — |
Countries
Czech Republic, Finland, Sweden
Outcome results
None listed