Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

Sanofi705 enrolled

Overview

The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026) for the prevention of Venous Thromboembolism \[VTE\] in patients undergoing total knee replacement \[TKR\] surgery. Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026, to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the pharmacokinetic parameters of AVE5026.

The randomization had to take place before the first study drug injection. The total duration of observation per participant was 27-33 days from surgery broken down as follows: * 4 to 10-day double-blind treatment period; * Follow-up period up to Day 30 ± 3 after surgery. Mandatory bilateral venography of the lower limbs had to be performed between 5 to 11 days after surgery.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

705

Conditions

Venous Thromboembolism

Interventions

Semuloparin sodiumDRUG

0.8 mL solution in Type I amber glass vials Subcutaneous injection

Placebo (for Enoxaparin sodium)DRUG

0.4 mL solution in ready-to-use prefilled syringe strictly identical in appearance containing the same volume but without active component Subcutaneous injection

Enoxaparin sodiumDRUG

0.4 mL solution in ready-to-use pre-filled syringe Subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient scheduled to undergo elective total knee replacement or revision of a primary procedure performed ≥ 6 months prior to study entry. Exclusion Criteria: * Any major orthopedic surgery in the 3 months prior to study entry; * Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome; * Known sensitivity to iodine or contrast dyes; * Recent stroke or myocardial infarction; * High risk of bleeding; * Treatment with other anti-thrombotic agents within 7 days prior to surgery; * Any contra-indication to Unfractionated Heparin or Low Molecular Weight Heparin; * Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Locations (19)

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Sanofi-Aventis Administrative Office

Sofia, Bulgaria

Outcomes

Primary Outcomes

Number of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death

VTE included any Deep Vein Thrombosis \[DVT\] identified on mandatory venography of the lower limbs; symptomatic DVT and/or non-fatal pulmonary embolism \[PE\] before mandatory examination; VTE related deaths included fatal PE or deaths which could not be attributed to a documented cause and for which PE could not be ruled out. All events were to be confirmed by a Central Independent Adjudication Committee \[CIAC\] based on venographies, scheduled or unscheduled, and other available diagnostic tests (ultrasonography, ventilation/perfusion lung scan, pulmonary angiography, autopsy report, etc).

Time frame: From surgery to Day 11 or the day of mandatory venography, whichever came first

Secondary Outcomes

Number of Participants Who Experienced DVT

Time frame: From surgery up to Day 11 or the day of mandatory venography, whichever came first

Number of Participants Who Experienced Symptomatic VTE

Symptomatic VTE included: * suspected DVT confirmed by the CIAC based on compression ultrasonography or venography; * suspected PE confirmed by the CIAC based on perfusion/ventilation lung scan, pulmonary angiography or spiral computerized tomography.

Time frame: From surgery up to Day 11 or the day of mandatory venography, whichever came first

Number of Participants Who Experienced Bleedings

Bleedings were centrally and blindly reviewed by the CIAC and classified as: * "Major" (fatal bleeding, bleeding that was retroperitoneal or intracranial or that involved any other critical organ (e.g. eye, adrenal gland, pericardium or spine), surgical site bleeding leading to intervention, non-surgical site bleeding requiring surgical intervention or with a bleeding index ≥2); * "Minor" (overt bleeding considered more than expected but not meeting the criteria for major bleeding); * "Criteria for bleeding event not satisfied" (not meeting the criteria for major or minor bleeding).

Time frame: From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.