The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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.
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 - "major" VTE includes any proximal DVT, symptomatic distal DVT and non-fatal Pulmonary Embolism (PE) as as confirmed by the CIAC.
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 ) - 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".
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 - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
Ohio
Country [11] 0 0
United States of America
State/province [11] 0 0
Pennsylvania
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
West Virginia
Country [14] 0 0
Argentina
State/province [14] 0 0
Buenos Aires
Country [15] 0 0
Argentina
State/province [15] 0 0
Capital Federal
Country [16] 0 0
Argentina
State/province [16] 0 0
Córdoba
Country [17] 0 0
Argentina
State/province [17] 0 0
Rosario
Country [18] 0 0
Argentina
State/province [18] 0 0
Santa Fe
Country [19] 0 0
Austria
State/province [19] 0 0
Graz
Country [20] 0 0
Austria
State/province [20] 0 0
Wels
Country [21] 0 0
Belarus
State/province [21] 0 0
Gomel
Country [22] 0 0
Belarus
State/province [22] 0 0
Minsk
Country [23] 0 0
Belarus
State/province [23] 0 0
Vitebsk
Country [24] 0 0
Belgium
State/province [24] 0 0
Genk
Country [25] 0 0
Belgium
State/province [25] 0 0
Gent
Country [26] 0 0
Brazil
State/province [26] 0 0
Belo Horizonte
Country [27] 0 0
Brazil
State/province [27] 0 0
Caxias Do Sul
Country [28] 0 0
Brazil
State/province [28] 0 0
Curitiba
Country [29] 0 0
Brazil
State/province [29] 0 0
Goiania
Country [30] 0 0
Brazil
State/province [30] 0 0
Joinville
Country [31] 0 0
Brazil
State/province [31] 0 0
Porto Alegre
Country [32] 0 0
Brazil
State/province [32] 0 0
Ribeirao Preto
Country [33] 0 0
Brazil
State/province [33] 0 0
Sao Jose Do Rio Preto
Country [34] 0 0
Brazil
State/province [34] 0 0
Sao Paulo
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Pleven
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Ruse
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Sofia
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Varna
Country [39] 0 0
Canada
State/province [39] 0 0
Edmonton
Country [40] 0 0
Canada
State/province [40] 0 0
Kitchener
Country [41] 0 0
Canada
State/province [41] 0 0
Montreal
Country [42] 0 0
Canada
State/province [42] 0 0
Red Deer
Country [43] 0 0
Canada
State/province [43] 0 0
Saint John
Country [44] 0 0
Canada
State/province [44] 0 0
Thunder Bay
Country [45] 0 0
Canada
State/province [45] 0 0
Vancouver
Country [46] 0 0
Chile
State/province [46] 0 0
Rancagua
Country [47] 0 0
Chile
State/province [47] 0 0
Santiago
Country [48] 0 0
China
State/province [48] 0 0
Baotou
Country [49] 0 0
China
State/province [49] 0 0
Changsha
Country [50] 0 0
China
State/province [50] 0 0
Fuzhou
Country [51] 0 0
China
State/province [51] 0 0
Guangzhou
Country [52] 0 0
China
State/province [52] 0 0
Haikou
Country [53] 0 0
China
State/province [53] 0 0
Nanjing
Country [54] 0 0
China
State/province [54] 0 0
Qingdao
Country [55] 0 0
China
State/province [55] 0 0
Shijiazhuang
Country [56] 0 0
China
State/province [56] 0 0
Tianjin
Country [57] 0 0
China
State/province [57] 0 0
Xi'An
Country [58] 0 0
Croatia
State/province [58] 0 0
Pozega
Country [59] 0 0
Croatia
State/province [59] 0 0
Pula
Country [60] 0 0
Croatia
State/province [60] 0 0
Zagreb
Country [61] 0 0
Czech Republic
State/province [61] 0 0
Brno
Country [62] 0 0
Czech Republic
State/province [62] 0 0
Jihlava
Country [63] 0 0
Czech Republic
State/province [63] 0 0
Kolin
Country [64] 0 0
Czech Republic
State/province [64] 0 0
Kromeriz
Country [65] 0 0
Czech Republic
State/province [65] 0 0
Liberec
Country [66] 0 0
Czech Republic
State/province [66] 0 0
Most
Country [67] 0 0
Czech Republic
State/province [67] 0 0
Ostrava
Country [68] 0 0
Czech Republic
State/province [68] 0 0
Pardubice
Country [69] 0 0
Czech Republic
State/province [69] 0 0
Praha 4
Country [70] 0 0
Czech Republic
State/province [70] 0 0
Praha 5
Country [71] 0 0
Czech Republic
State/province [71] 0 0
Praha 6
Country [72] 0 0
Czech Republic
State/province [72] 0 0
Ricany
Country [73] 0 0
Czech Republic
State/province [73] 0 0
Usti Nad Labem
Country [74] 0 0
Denmark
State/province [74] 0 0
København Nv
Country [75] 0 0
Denmark
State/province [75] 0 0
Odense C
Country [76] 0 0
Estonia
State/province [76] 0 0
Tallinn
Country [77] 0 0
Estonia
State/province [77] 0 0
Tartu
Country [78] 0 0
Germany
State/province [78] 0 0
Bochum
Country [79] 0 0
Germany
State/province [79] 0 0
Castrop-Rauxel
Country [80] 0 0
Germany
State/province [80] 0 0
Dresden
Country [81] 0 0
Germany
State/province [81] 0 0
Hannover
Country [82] 0 0
Germany
State/province [82] 0 0
Heidelberg
Country [83] 0 0
Germany
State/province [83] 0 0
Homburg
Country [84] 0 0
Germany
State/province [84] 0 0
Lübeck
Country [85] 0 0
Germany
State/province [85] 0 0
Magdeburg
Country [86] 0 0
Germany
State/province [86] 0 0
München
Country [87] 0 0
Germany
State/province [87] 0 0
Stralsund
Country [88] 0 0
Greece
State/province [88] 0 0
Heraklion
Country [89] 0 0
Hungary
State/province [89] 0 0
Debrecen
Country [90] 0 0
Hungary
State/province [90] 0 0
Kistarcsa
Country [91] 0 0
Hungary
State/province [91] 0 0
Szeged
Country [92] 0 0
Hungary
State/province [92] 0 0
Szekesfehervar
Country [93] 0 0
Hungary
State/province [93] 0 0
Szolnok
Country [94] 0 0
India
State/province [94] 0 0
Ahmedabad
Country [95] 0 0
India
State/province [95] 0 0
Andhra Pradesh
Country [96] 0 0
India
State/province [96] 0 0
Bangalore
Country [97] 0 0
India
State/province [97] 0 0
Banglore
Country [98] 0 0
India
State/province [98] 0 0
Bhopal
Country [99] 0 0
India
State/province [99] 0 0
Chennai
Country [100] 0 0
India
State/province [100] 0 0
Cochin
Country [101] 0 0
India
State/province [101] 0 0
Coimbatore
Country [102] 0 0
India
State/province [102] 0 0
Gujarat
Country [103] 0 0
India
State/province [103] 0 0
Hyderabad
Country [104] 0 0
India
State/province [104] 0 0
Jaipur
Country [105] 0 0
India
State/province [105] 0 0
Kochi
Country [106] 0 0
India
State/province [106] 0 0
Lucknow
Country [107] 0 0
India
State/province [107] 0 0
Ludhiana
Country [108] 0 0
India
State/province [108] 0 0
Luknow
Country [109] 0 0
India
State/province [109] 0 0
Mangalore
Country [110] 0 0
India
State/province [110] 0 0
Nagpur
Country [111] 0 0
India
State/province [111] 0 0
New Delhi
Country [112] 0 0
India
State/province [112] 0 0
Pune
Country [113] 0 0
India
State/province [113] 0 0
Punjgutta
Country [114] 0 0
Italy
State/province [114] 0 0
Aviano
Country [115] 0 0
Italy
State/province [115] 0 0
Genova
Country [116] 0 0
Italy
State/province [116] 0 0
Milano
Country [117] 0 0
Italy
State/province [117] 0 0
Padova
Country [118] 0 0
Italy
State/province [118] 0 0
Parma
Country [119] 0 0
Italy
State/province [119] 0 0
Piacenza
Country [120] 0 0
Italy
State/province [120] 0 0
Pordenone
Country [121] 0 0
Italy
State/province [121] 0 0
Reggio Emilia
Country [122] 0 0
Italy
State/province [122] 0 0
San Donato Milanese
Country [123] 0 0
Italy
State/province [123] 0 0
Trieste
Country [124] 0 0
Korea, Republic of
State/province [124] 0 0
Daegu
Country [125] 0 0
Korea, Republic of
State/province [125] 0 0
Goyang
Country [126] 0 0
Korea, Republic of
State/province [126] 0 0
Gyeonggi-do
Country [127] 0 0
Korea, Republic of
State/province [127] 0 0
Incheon
Country [128] 0 0
Korea, Republic of
State/province [128] 0 0
Seoul
Country [129] 0 0
Korea, Republic of
State/province [129] 0 0
Suwon
Country [130] 0 0
Latvia
State/province [130] 0 0
Daugavpils
Country [131] 0 0
Latvia
State/province [131] 0 0
Riga
Country [132] 0 0
Lithuania
State/province [132] 0 0
Kaunas
Country [133] 0 0
Lithuania
State/province [133] 0 0
Vilnius
Country [134] 0 0
Mexico
State/province [134] 0 0
Guadalajara
Country [135] 0 0
Mexico
State/province [135] 0 0
Mazatlán
Country [136] 0 0
New Zealand
State/province [136] 0 0
Christchurch
Country [137] 0 0
New Zealand
State/province [137] 0 0
Nelson South
Country [138] 0 0
Norway
State/province [138] 0 0
Trondheim
Country [139] 0 0
Peru
State/province [139] 0 0
Callao
Country [140] 0 0
Peru
State/province [140] 0 0
Lima
Country [141] 0 0
Poland
State/province [141] 0 0
Bydgoszcz
Country [142] 0 0
Poland
State/province [142] 0 0
Gdansk
Country [143] 0 0
Poland
State/province [143] 0 0
Krakow
Country [144] 0 0
Poland
State/province [144] 0 0
Lodz
Country [145] 0 0
Poland
State/province [145] 0 0
Lublin
Country [146] 0 0
Poland
State/province [146] 0 0
Poznan
Country [147] 0 0
Poland
State/province [147] 0 0
Sosnowiec
Country [148] 0 0
Poland
State/province [148] 0 0
Szczecin
Country [149] 0 0
Poland
State/province [149] 0 0
Torun
Country [150] 0 0
Poland
State/province [150] 0 0
Warszawa
Country [151] 0 0
Poland
State/province [151] 0 0
Wroclaw
Country [152] 0 0
Romania
State/province [152] 0 0
Cluj-Napoca
Country [153] 0 0
Romania
State/province [153] 0 0
Oradea
Country [154] 0 0
Romania
State/province [154] 0 0
Timisoara
Country [155] 0 0
Russian Federation
State/province [155] 0 0
Krasnodar
Country [156] 0 0
Russian Federation
State/province [156] 0 0
Krasnoyarsk
Country [157] 0 0
Russian Federation
State/province [157] 0 0
Moscow
Country [158] 0 0
Russian Federation
State/province [158] 0 0
Novosibirsk
Country [159] 0 0
Russian Federation
State/province [159] 0 0
Omsk
Country [160] 0 0
Russian Federation
State/province [160] 0 0
Sestroretsk,
Country [161] 0 0
Russian Federation
State/province [161] 0 0
St-Petersburg
Country [162] 0 0
Russian Federation
State/province [162] 0 0
St. Petersburg
Country [163] 0 0
Russian Federation
State/province [163] 0 0
St.-Petersburg
Country [164] 0 0
Russian Federation
State/province [164] 0 0
Tomsk
Country [165] 0 0
Russian Federation
State/province [165] 0 0
Vsevolozhsk
Country [166] 0 0
Russian Federation
State/province [166] 0 0
Yaroslavl
Country [167] 0 0
Serbia
State/province [167] 0 0
Belgrade
Country [168] 0 0
Serbia
State/province [168] 0 0
Novi Sad
Country [169] 0 0
Slovakia
State/province [169] 0 0
Bratislava
Country [170] 0 0
Slovenia
State/province [170] 0 0
Celje
Country [171] 0 0
Slovenia
State/province [171] 0 0
Maribor
Country [172] 0 0
South Africa
State/province [172] 0 0
Cape Town
Country [173] 0 0
South Africa
State/province [173] 0 0
Worcester
Country [174] 0 0
Spain
State/province [174] 0 0
Barcelona
Country [175] 0 0
Spain
State/province [175] 0 0
Madrid
Country [176] 0 0
Sweden
State/province [176] 0 0
Kungälv
Country [177] 0 0
Sweden
State/province [177] 0 0
Norrköping
Country [178] 0 0
Sweden
State/province [178] 0 0
Stockholm
Country [179] 0 0
Sweden
State/province [179] 0 0
Varberg
Country [180] 0 0
Turkey
State/province [180] 0 0
Istanbul
Country [181] 0 0
Turkey
State/province [181] 0 0
Izmir
Country [182] 0 0
Ukraine
State/province [182] 0 0
Cherkasy
Country [183] 0 0
Ukraine
State/province [183] 0 0
Donetsk
Country [184] 0 0
Ukraine
State/province [184] 0 0
Kharkiv
Country [185] 0 0
Ukraine
State/province [185] 0 0
Kyiv
Country [186] 0 0
Ukraine
State/province [186] 0 0
Odessa
Country [187] 0 0
United Kingdom
State/province [187] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT00679588
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

Summary results
Other publications