AzTrials
AzTrials

Venous ThromboembolismPhase 3SAVE-ABDONCT00679588

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Major Abdominal Surgery

A Phase 3 study testing Semuloparin Sodium and Enoxaparin sodium in people with Venous Thromboembolism, run by Sanofi at 270 sites in 39 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Venous Thromboembolism
What is being tested?
Semuloparin Sodium and Enoxaparin sodium
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
4,413 participants
Where
270 sitesin 39 countries
Study dates
Apr 2008to Aug 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

270 sites in 39 countries.

270 sites in 39 countries

India29 sites

  • Investigational Site Number 356005

    Ahmedabad, 380 006

  • Investigational Site Number 356004

    Ahmedabad, 380 008

  • Investigational Site Number 356033

    Andhra Pradesh

  • Investigational Site Number 356011

    Bangalore, 560 034

  • Investigational Site Number 356027

    Bangalore, 560029

  • Investigational Site Number 356008

    Bangalore

  • Investigational Site Number 356019

    Banglore, 560054

  • Investigational Site Number 356031

    Bhopal

  • Investigational Site Number 356014

    Chennai, 600 096

  • Investigational Site Number 356018

    Chennai, 600010

  • Investigational Site Number 356016

    Chennai, 600035

  • Investigational Site Number 356021

    Chennai, 600101

  • Investigational Site Number 356006

    Coimbatore, 641037

  • Investigational Site Number 356025

    Gujarat, 380006

  • Investigational Site Number 356028

    Hyderabad, 500004

  • Investigational Site Number 356010

    Hyderabad, 500082

  • Investigational Site Number 356002

    Jaipur, 302013

  • Investigational Site Number 356022

    Jaipur

  • Investigational Site Number 356013

    Kochi, 682026

  • Investigational Site Number 356007

    Kochi, 682304

  • Investigational Site Number 356003

    Lucknow, 226014

  • Investigational Site Number 356026

    Lucknow

  • Investigational Site Number 356032

    Ludhiana, 141001

  • Investigational Site Number 356001

    Mangalore

  • Investigational Site Number 356030

    Nagpur

  • Investigational Site Number 356009

    New Delhi, 110085

  • Investigational Site Number 356023

    Pune, 411 011

  • Investigational Site Number 356015

    Pune, 411001

  • Investigational Site Number 356012

    Punjgutta

Other trials in India

United States25 sites

  • Investigational Site Number 840026

    Birmingham, Alabama, 35209

  • Investigational Site Number 840035

    Birmingham, Alabama, 35209

  • Investigational Site Number 840042

    Birmingham, Alabama, 35209

  • Investigational Site Number 840002

    Birmingham, Alabama, 35234

  • Investigational Site Number 840029

    Clearwater, Florida, 33756

  • Investigational Site Number 840009

    Columbus, Georgia, 31904

  • Investigational Site Number 840051

    Columbus, Ohio, 43210

  • Investigational Site Number 840031

    Corlton, California, 82324

  • Investigational Site Number 840021

    Denver, Colorado, 80262

  • Investigational Site Number 840037

    Hazard, Kentucky, 41701

  • Investigational Site Number 840025

    Houston, Texas, 77024

  • Investigational Site Number 840050

    Houston, Texas, 77070

  • Investigational Site Number 840007

    Huntingdon Beach, California, 92647

  • Investigational Site Number 840017

    Jacksonville, Florida, 32209

  • Investigational Site Number 840014

    Los Angeles, California, 90033

  • Investigational Site Number 840032

    Lubbock, Texas, 79409

  • Investigational Site Number 840019

    Maywood, Illinois, 60153

  • Investigational Site Number 840044

    Miami, Florida, 33136

  • Investigational Site Number 840043

    Morgantown, West Virginia, 26506

  • Investigational Site Number 840015

    Orlando, Florida, 32804

  • Investigational Site Number 840006

    Pittsburgh, Pennsylvania, 15240

  • Investigational Site Number 840011

    Sant Barbara, California, 93105

  • Investigational Site Number 840036

    Springfield, Illinois, 62702

  • Investigational Site Number 840008

    St Louis, Missouri, 63104

  • Investigational Site Number 840020

    Teaneck, New Jersey, 07666

Other trials in United States

Russia20 sites

  • Investigational Site Number 643019

    Krasnodar, 350086

  • Investigational Site Number 643006

    Krasnoyarsk, 660058

  • Investigational Site Number 643003

    Moscow, 105229

  • Investigational Site Number 643001

    Moscow, 115280

  • Investigational Site Number 643002

    Moscow, 119048

  • Investigational Site Number 643020

    Moscow, 119415

  • Investigational Site Number 643021

    Moscow, 119991

  • Investigational Site Number 643025

    Moscow, 125367

  • Investigational Site Number 643008

    Novosibirsk, 630047

  • Investigational Site Number 643007

    Novosibirsk, 630054

  • Investigational Site Number 643026

    Omsk, 644013

  • Investigational Site Number 643011

    Saint Petersburg, 191104

  • Investigational Site Number 643010

    Saint Petersburg, 194291

  • Investigational Site Number 643009

    Saint Petersburg, 194354

  • Investigational Site Number 643018

    Saint Petersburg, 195067

  • Investigational Site Number 643017

    Saint Petersburg, 199004

  • Investigational Site Number 643015

    Sestroretsk, 197706

  • Investigational Site Number 643012

    Tomsk, 634063

  • Investigational Site Number 643016

    Vsevolozhsk, 188640

  • Investigational Site Number 643014

    Yaroslavl, 150062

Other trials in Russia

Poland18 sites

  • Investigational Site Number 616001

    Bydgoszcz, 85-094

  • Investigational Site Number 616003

    Bydgoszcz, 85-168

  • Investigational Site Number 616006

    Gdansk

  • Investigational Site Number 616005

    Krakow, 31-501

  • Investigational Site Number 616018

    Krakow, 31-826

  • Investigational Site Number 616020

    Krakow, 31-913

  • Investigational Site Number 616009

    Lodz, 90-153

  • Investigational Site Number 616002

    Lodz, 90-647

  • Investigational Site Number 616010

    Lublin, 20-081

  • Investigational Site Number 616012

    Poznan, 60-747

  • Investigational Site Number 616015

    Sosnowiec, 41-200

  • Investigational Site Number 616013

    Szczecin, 70-111

  • Investigational Site Number 616011

    Torun, 87-100

  • Investigational Site Number 616004

    Warsaw, 02-097

  • Investigational Site Number 616014

    Warsaw, 03-242

  • Investigational Site Number 616008

    Wroclaw, 50 -556

  • Investigational Site Number 616007

    Wroclaw, 50-326

  • Investigational Site Number 616016

    Wroclaw, 51-124

Other trials in Poland

Brazil14 sites

  • Investigational Site Number 076003

    Belo Horizonte, 30150-221

  • Investigational Site Number 076010

    Belo Horizonte, 30380-490

  • Investigational Site Number 076014

    Caxias do Sul, 95001-960

  • Investigational Site Number 076012

    Curitiba, 80050-350

  • Investigational Site Number 076005

    Curitiba, 81520-060

  • Investigational Site Number 076006

    Goiânia, 74605-070

  • Investigational Site Number 076011

    Joinville, 89202-000

  • Investigational Site Number 076007

    Porto Alegre, 90035 003

  • Investigational Site Number 076009

    Porto Alegre, 90610-000

  • Investigational Site Number 076015

    Ribeirão Preto, 14049-900

  • Investigational Site Number 076013

    São José do Rio Preto, 15090-000

  • Investigational Site Number 076004

    São Paulo, 01323-001

  • Investigational Site Number 076002

    São Paulo, 05403-000

  • Investigational Site Number 076008

    São Paulo, 08270-070

Other trials in Brazil

Czechia14 sites

  • Investigational Site Number 203007

    Brno, 62500

  • Investigational Site Number 203001

    Brno, 65691

  • Investigational Site Number 203011

    Jihlava, 58633

  • Investigational Site Number 203015

    Kolín, 28020

  • Investigational Site Number 203009

    Kroměříž, 76755

  • Investigational Site Number 203004

    Liberec, 46063

  • Investigational Site Number 203014

    Most, 43464

  • Investigational Site Number 203003

    Ostrava, 72880

  • Investigational Site Number 203012

    Pardubice, 53203

  • Investigational Site Number 203008

    Prague, 14059

  • Investigational Site Number 203006

    Prague, 15006

  • Investigational Site Number 203002

    Prague, 16902

  • Investigational Site Number 203016

    Říčany, 25001

  • Investigational Site Number 203010

    Ústí nad Labem, 40113

Other trials in Czechia

China11 sites

  • Investigational Site Number 156011

    Baotou, 014010

  • Investigational Site Number 156012

    Changsha, 410008

  • Investigational Site Number 156010

    Changsha, 410013

  • Investigational Site Number 156006

    Fuzhou, 354200

  • Investigational Site Number 156003

    Guangzhou, 510060

  • Investigational Site Number 156013

    Haikou, 570208

  • Investigational Site Number 156005

    Nanjing, 210006

  • Investigational Site Number 156008

    Qingdao, 266003

  • Investigational Site Number 156001

    Shijiazhuang, 050051

  • Investigational Site Number 156014

    Tianjin, 300121

  • Investigational Site Number 156004

    Xi'an, 710038

Other trials in China

Germany11 sites

  • Investigational Site Number 276011

    Bochum, 44791

  • Investigational Site Number 276015

    Castrop-Rauxel, 44575

  • Investigational Site Number 276018

    Castrop-Rauxel, 44575

  • Investigational Site Number 276006

    Dresden, 01067

  • Investigational Site Number 276012

    Hanover, 30625

  • Investigational Site Number 276002

    Heidelberg, 69120

  • Investigational Site Number 276004

    Homburg, 66421

  • Investigational Site Number 276014

    Lübeck, 23538

  • Investigational Site Number 276016

    Magdeburg, 39130

  • Investigational Site Number 276013

    München, 81675

  • Investigational Site Number 276001

    Stralsund, 18435

Other trials in Germany

Italy11 sites

  • Investigational Site Number 380009

    Aviano, 33081

  • Investigational Site Number 380001

    Genova, 16132

  • Investigational Site Number 380015

    Genova, 16132

  • Investigational Site Number 380006

    Milan, 20132

  • Investigational Site Number 380004

    Padova, 35128

  • Investigational Site Number 380008

    Parma, 43100

  • Investigational Site Number 380013

    Piacenza, 29100

  • Investigational Site Number 380012

    Pordenone, 33170

  • Investigational Site Number 380005

    Reggio Emilia, 42100

  • Investigational Site Number 380011

    San Donato Milanese, 20097

  • Investigational Site Number 380007

    Trieste, 34149

Other trials in Italy

South Korea10 sites

  • Investigational Site Number 410007

    Daegu, 700-712

  • Investigational Site Number 410006

    Goyang, 410-773

  • Investigational Site Number 410001

    Gyeonggi-do, 420-767

  • Investigational Site Number 410009

    Incheon, 400-711

  • Investigational Site Number 410011

    Seoul, 110-744

  • Investigational Site Number 410004

    Seoul, 120-752

  • Investigational Site Number 410002

    Seoul, 135-710

  • Investigational Site Number 410010

    Seoul, 135-720

  • Investigational Site Number 410008

    Seoul, 138-878

  • Investigational Site Number 410003

    Suwon, 443-721

Other trials in South Korea

Argentina8 sites

  • Investigational Site Number 032002

    Buenos Aires, 1155

  • Investigational Site Number 032001

    Buenos Aires, 1416

  • Investigational Site Number 032004

    Buenos Aires

  • Investigational Site Number 032007

    Capital Federal, 1039

  • Investigational Site Number 032008

    Capital Federal, C1408INH

  • Investigational Site Number 032014

    Córdoba, X5000AAI

  • Investigational Site Number 032012

    Rosario, 2000

  • Investigational Site Number 032005

    Santa Fe, S3000EPV

Other trials in Argentina

Belarus8 sites

  • Investigational Site Number 112001

    Homyel, 246012

  • Investigational Site Number 112006

    Homyel, 246012

  • Investigational Site Number 112003

    Minsk, 220013

  • Investigational Site Number 112008

    Minsk, 223040

  • Investigational Site Number 112002

    Minsk

  • Investigational Site Number 112005

    Minsk

  • Investigational Site Number 112004

    Vitebsk, 210603

  • Investigational Site Number 112007

    Vitebsk

Other trials in Belarus

Bulgaria8 sites

  • Investigational Site Number 100004

    Pleven, 5800

  • Investigational Site Number 100003

    Rousse, 7002

  • Investigational Site Number 100011

    Sofia, 1407

  • Investigational Site Number 100005

    Sofia, 1606

  • Investigational Site Number 100008

    Sofia, 1606

  • Investigational Site Number 100009

    Sofia, 1606

  • Investigational Site Number 100006

    Varna, 9010

  • Investigational Site Number 100010

    Varna, 9010

Other trials in Bulgaria

Ukraine8 sites

  • Investigational Site Number 804003

    Cherkasy, 18009

  • Investigational Site Number 804007

    Donetsk, 83092

  • Investigational Site Number 804010

    Donetsk, 83092

  • Investigational Site Number 804011

    Kharkiv, 61037

  • Investigational Site Number 804005

    Kyiv, 3022

  • Investigational Site Number 804002

    Kyiv

  • Investigational Site Number 804004

    Kyiv

  • Investigational Site Number 804008

    Odesa, 65025

Other trials in Ukraine

Canada7 sites

  • Investigational Site Number 124001

    Edmonton, T6G 2B7

  • Investigational Site Number 124004

    Kitchener, N2G 1G3

  • Investigational Site Number 124010

    Montreal, H3G 1A4

  • Investigational Site Number 124011

    Red Deer, T4N 4E6

  • Investigational Site Number 124009

    Saint John, E2L 4L2

  • Investigational Site Number 124002

    Thunder Bay, P7B 6V1

  • Investigational Site Number 124007

    Vancouver, V5Z 4E3

Other trials in Canada

Peru6 sites

  • Investigational Site Number 604003

    Callao, Callao 02

  • Investigational Site Number 604004

    Callao

  • Investigational Site Number 604006

    Lima, LIMA 11

  • Investigational Site Number 604001

    Lima, LIMA 13

  • Investigational Site Number 604005

    Lima, LIMA 18

  • Investigational Site Number 604002

    Lima, Lima 29

Other trials in Peru

Romania6 sites

  • Investigational Site Number 642003

    Cluj-Napoca, 400006

  • Investigational Site Number 642006

    Cluj-Napoca, 400015

  • Investigational Site Number 642005

    Cluj-Napoca, 400132

  • Investigational Site Number 642001

    Oradea, 410169

  • Investigational Site Number 642004

    Oradea, 410169

  • Investigational Site Number 642002

    Timișoara, 300736

Other trials in Romania

Hungary5 sites

  • Investigational Site Number 348007

    Debrecen, 4032

  • Investigational Site Number 348009

    Kistarcsa, 2143

  • Investigational Site Number 348008

    Szeged, 6720

  • Investigational Site Number 348004

    Székesfehérvár, 8000

  • Investigational Site Number 348003

    Szolnok, 5000

Other trials in Hungary

Australia4 sites

  • Investigational Site Number 036002

    Box Hill, 3128

  • Investigational Site Number 036003

    Box Hill, 3128

  • Investigational Site Number 036001

    Kogarah, 2217

  • Investigational Site Number 036008

    Redcliffe, 4020

Other trials in Australia

Sweden4 sites

  • Investigational Site Number 752002

    Kungälv, 442 83

  • Investigational Site Number 752004

    Norrköping, 601 82

  • Investigational Site Number 752001

    Stockholm, 14186

  • Investigational Site Number 752003

    Varberg, 432 81

Other trials in Sweden

Turkey (Türkiye)4 sites

  • Investigational Site Number 792003

    Istanbul, 34147

  • Investigational Site Number 792001

    Istanbul, 34390

  • Investigational Site Number 792006

    Istanbul

  • Investigational Site Number 792007

    Izmir, 35360

Other trials in Turkey (Türkiye)

Croatia3 sites

  • Investigational Site Number 191004

    Požega, 34000

  • Investigational Site Number 191001

    Pula, 52100

  • Investigational Site Number 191002

    Zagreb, 10000

Other trials in Croatia

Estonia3 sites

  • Investigational Site Number 233003

    Tallinn, 13419

  • Investigational Site Number 233001

    Tartu, 50406

  • Investigational Site Number 233002

    Tartu, 50406

Other trials in Estonia

Latvia3 sites

  • Investigational Site Number 428004

    Daugavpils, LV-5417

  • Investigational Site Number 428003

    Riga, LV-1002

  • Investigational Site Number 428002

    Riga, LV-1038

Other trials in Latvia

Lithuania3 sites

  • Investigational Site Number 440003

    Kaunas, LT-47144

  • Investigational Site Number 440001

    Kaunas, LT-50009

  • Investigational Site Number 440002

    Vilnius, LT-10207

Other trials in Lithuania

New Zealand3 sites

  • Investigational Site Number 554003

    Christchurch, 8011

  • Investigational Site Number 554001

    Christchurch, 8014

  • Investigational Site Number 554002

    Nelson South, 7010

Other trials in New Zealand

Serbia3 sites

  • Investigational Site Number 688001

    Belgrade, 11080

  • Investigational Site Number 688004

    Belgrade, 11080

  • Investigational Site Number 688002

    Novi Sad, 21000

Other trials in Serbia

South Africa3 sites

  • Investigational Site Number 710001

    Cape Town, 7130

  • Investigational Site Number 710004

    Cape Town

  • Investigational Site Number 710003

    Worcester, 6850

Other trials in South Africa

Austria2 sites

  • Investigational Site Number 040001

    Graz, 8036

  • Investigational Site Number 040002

    Wels, 4600

Other trials in Austria

Belgium2 sites

  • Investigational Site Number 056002

    Genk, 3600

  • Investigational Site Number 056001

    Ghent, 9000

Other trials in Belgium

Chile2 sites

  • Investigational Site Number 152002

    Rancagua

  • Investigational Site Number 152001

    Santiago, 838-0456

Other trials in Chile

Denmark2 sites

  • Investigational Site Number 208001

    København NV, 2400

  • Investigational Site Number 208002

    Odense C, 5000

Other trials in Denmark

Mexico2 sites

  • Investigational Site Number 484001

    Guadalajara, 44340

  • Investigational Site Number 484006

    Mazatlán, 82110

Other trials in Mexico

Slovenia2 sites

  • Investigational Site Number 705001

    Celje, 3000

  • Investigational Site Number 705002

    Maribor, 2000

Other trials in Slovenia

Spain2 sites

  • Investigational Site Number 724001

    Barcelona, 08907

  • Investigational Site Number 724002

    Madrid, 28007

Other trials in Spain

Greece1 site

  • Investigational Site Number 300002

    Heraklion, 71110

Other trials in Greece

Norway1 site

  • Investigational Site Number 578001

    Trondheim, 7006

Other trials in Norway

Slovakia1 site

  • Investigational Site Number 703001

    Bratislava, 821 01

Other trials in Slovakia

United Kingdom1 site

  • Investigational Site Number 826001

    London, SE5 9PJ

Other trials in United Kingdom

About this study

Official 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

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.

Read the 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.

Being tested
Semuloparin Sodium, Enoxaparin sodium, Placebo
Keywords
Digestive System Surgical Procedure, Urologic Surgical Procedure, Prevention of venous thromboembolism, Abdominal surgery
Medical subject headings
Venous Thromboembolism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Semuloparin SodiumDrug

    Also called AVE5026

    0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

    Subcutaneous injection

  • Enoxaparin sodiumDrug

    Also called Lovenox®

    0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

    Subcutaneous injection

  • PlaceboDrug

    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

Study groups in NCT00679588
Study groupRoleWhat they receive
SemuloparinExperimentalSemuloparin 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)
Receives: Drug: Semuloparin Sodium; Drug: Placebo
EnoxaparinActive comparatorEnoxaparin 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)
Receives: Drug: Enoxaparin sodium; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first

Secondary outcomes (3)

  1. 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.

    Measured: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first

  2. 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".

    Measured: From 1st study drug injection up to 3 days after last study drug injection

  3. 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.

    Measured: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionAug 2010
  4. Study completionAug 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
4,413 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00679588
Sponsor's protocol ID
EFC6520
Other IDs
2007-007942-36
Acronym
SAVE-ABDO
Status last verified
Nov 2013
First submitted
7 May 2008
Last updated
16 Dec 2013
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 24374549

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Semuloparin Sodium and Enoxaparin sodium in people with Venous Thromboembolism, run by Sanofi at 270 sites in 39 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 270 sites in India, United States, Russia, Poland, Brazil and 34 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experience Venous Thromboembolism Event (VTE) or All-cause Death (time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever comes first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00679588, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2013.

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