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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00679588
Registration number
NCT00679588
Ethics application status
Date submitted
7/05/2008
Date registered
19/05/2008
Date last updated
16/12/2013
Titles & IDs
Public title
Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
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Scientific title
A Multinational, Multicenter, Randomized, Double Blind Study Comparing the Efficacy and Safety of AVE5026 With Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery
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Secondary ID [1]
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2007-007942-36
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Secondary ID [2]
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EFC6520
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Universal Trial Number (UTN)
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Trial acronym
SAVE-ABDO
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism
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0
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Condition category
Condition code
Cardiovascular
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0
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0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
0
0
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Semuloparin Sodium
Treatment: Drugs - Enoxaparin sodium
Treatment: Drugs - Placebo
Experimental: Semuloparin - 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)
Active comparator: Enoxaparin - 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)
Treatment: Drugs: Semuloparin Sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Treatment: Drugs: Enoxaparin sodium
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe
Subcutaneous injection
Treatment: Drugs: Placebo
0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component
Subcutaneous injection
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death
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Assessment method [1]
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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.
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Timepoint [1]
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From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
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Secondary outcome [1]
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Percentage of Participants Who Experience "major" VTE or All-cause Death
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Assessment method [1]
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"major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.
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Timepoint [1]
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From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
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Secondary outcome [2]
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Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings )
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Assessment method [2]
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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".
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Timepoint [2]
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From 1st study drug injection up to 3 days after last study drug injection
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Secondary outcome [3]
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Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
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Assessment method [3]
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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.
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Timepoint [3]
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From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
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Eligibility
Key inclusion criteria
* 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* 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.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/04/2008
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/08/2010
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Sample size
Target
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Accrual to date
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Final
4413
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Investigational Site Number 036002 - Box Hill
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Recruitment hospital [2]
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Investigational Site Number 036003 - Box Hill
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Investigational Site Number 036001 - Kogarah
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Recruitment hospital [4]
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Investigational Site Number 036008 - Redcliffe
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Recruitment postcode(s) [1]
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3128 - Box Hill
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2217 - Kogarah
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Recruitment postcode(s) [3]
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4020 - Redcliffe
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Korea, Republic of
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Incheon
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Seoul
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Suwon
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United Kingdom
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Funding & Sponsors
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Commercial sector/industry
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Name
Sanofi
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00679588
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Trial related presentations / publications
Kakkar AK, Agnelli G, Fisher W, George D, Lassen MR, Mismetti P, Mouret P, Murphy J, Lawson F, Turpie AG; SAVE-ABDO Investigators. Preoperative enoxaparin versus postoperative semuloparin thromboprophylaxis in major abdominal surgery: a randomized controlled trial. Ann Surg. 2014 Jun;259(6):1073-9. doi: 10.1097/SLA.0000000000000430.
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Public notes
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Contacts
Principal investigator
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Ajay Kakkar, Prof., MD, PhD
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Queen Mary's School of Medicine & Dentistry, London (UK)
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No information has been provided regarding IPD availability
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Results not provided in
https://clinicaltrials.gov/study/NCT00679588
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