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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
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
Secondary ID [1] 0 0
2007-007942-36
Secondary ID [2] 0 0
EFC6520
Universal Trial Number (UTN)
Trial acronym
SAVE-ABDO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death
Timepoint [1] 0 0
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Secondary outcome [1] 0 0
Percentage of Participants Who Experience "major" VTE or All-cause Death
Timepoint [1] 0 0
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first
Secondary outcome [2] 0 0
Percentage of Participants Who Experience Clinically Relevant Bleedings ("major" and "clinically relevant non-major" bleedings )
Timepoint [2] 0 0
From 1st study drug injection up to 3 days after last study drug injection
Secondary outcome [3] 0 0
Percentage of Participants requiring the initiation of curative anticoagulant or thrombolytic treatment after VTE assessment
Timepoint [3] 0 0
From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/04/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2010
Sample size
Target
Accrual to date
Final
4413
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Investigational Site Number 036002 - Box Hill
Recruitment hospital [2] 0 0
Investigational Site Number 036003 - Box Hill
Recruitment hospital [3] 0 0
Investigational Site Number 036001 - Kogarah
Recruitment hospital [4] 0 0
Investigational Site Number 036008 - Redcliffe
Recruitment postcode(s) [1] 0 0
3128 - Box Hill
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
4020 - Redcliffe
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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United States of America
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California
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United States of America
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Colorado
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Florida
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Georgia
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Missouri
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Ohio
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Pennsylvania
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Texas
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West Virginia
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Argentina
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Buenos Aires
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Capital Federal
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Córdoba
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Rosario
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Santa Fe
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Graz
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Gomel
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Minsk
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ajay Kakkar, Prof., MD, PhD
Address 0 0
Queen Mary's School of Medicine & Dentistry, London (UK)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00679588