Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
- Conditions
- Venous Thromboembolism
- Interventions
- Registration Number
- NCT00679588
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to compare the efficacy and safety of once daily (q.d.) subcutaneous (s.c.) injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of Enoxaparin for the prevention of Venous Thromboembolic Events (VTE) in patients undergoing major abdominal surgery.
The secondary objectives are to evaluate the safety of Semuloparin sodium (AVE5026) and to document Semuloparin sodium (AVE5026) exposure in this population.
- Detailed Description
Randomization has to take place prior to the surgery.
The total duration of observation per participant is 35-42 days from surgery broken down as follows:
* 7 to 10-day double-blind treatment period;
* 28 to 35-day follow-up period.
Mandatory bilateral venography of the lower limbs has to be performed between 7 to 11 days after surgery.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4413
-
Patient undergoing major abdominal surgery (open surgery under general anesthesia lasting more than 45 minutes in the peritoneal and/or retroperitoneal space and/or pelvis).
-
Patient <60 years of age had to have one of the following additional risk factors for VTE:
- History of VTE,
- Obesity,
- Chronic Heart failure,
- Chronic Respiratory Failure,
- Inflammatory Bowel Disease,
- Cancer Surgery.
- Any major orthopedic or general surgery in the 3 months prior to study start;
- Clinical signs or symptoms of DVT or PE within the last 12 months or known post phlebitic syndrome;
- Any contra-indications to the performance of venography;
- High risk of bleeding;
- Known hypersensitivity to heparin or Enoxaparin sodium;
- End stage renal disease or patient on dialysis.
The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semuloparin Semuloparin Sodium Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given 8 hours after surgery (placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind) Semuloparin Placebo Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given 8 hours after surgery (placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind) Enoxaparin Enoxaparin sodium Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium (placebo for Semuloparin sodium 8 hours after surgery to maintain the blind) Enoxaparin Placebo Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment \[SRI\]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium (placebo for Semuloparin sodium 8 hours after surgery to maintain the blind)
- Primary Outcome Measures
Name Time Method Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first VTE includes any proximal or distal Deep Vein Thrombosis (DVT) (symptomatic or not) and non-fatal Pulmonary Embolism (PE) as confirmed by a Central Independent Adjudication Committee (CIAC) after review of mandatory bilateral venograms and diagnostic tests for VTE.
All-cause deaths includes fatal PE and deaths for other reason than PE.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Experience "major" VTE or All-cause Death From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first "major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.
Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings ) From 1st study drug injection up to 3 days after last study drug injection Bleedings are centrally and blindly reviewed by the CIAC and classified as:
* "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation);
* "clinically relevant non-major" (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by health care professional);
* "Nonclinically relevant bleeding".Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory venography.
Trial Locations
- Locations (270)
Investigational Site Number 840026
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840035
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840042
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840002
🇺🇸Birmingham, Alabama, United States
Investigational Site Number 840031
🇺🇸Corlton, California, United States
Investigational Site Number 840007
🇺🇸Huntingdon Beach, California, United States
Investigational Site Number 840014
🇺🇸Los Angeles, California, United States
Investigational Site Number 840011
🇺🇸Sant Barbara, California, United States
Investigational Site Number 840021
🇺🇸Denver, Colorado, United States
Investigational Site Number 840029
🇺🇸Clearwater, Florida, United States
Scroll for more (260 remaining)Investigational Site Number 840026🇺🇸Birmingham, Alabama, United States