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Completed

NCT Number: NCT00721760

Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Hip Fracture Surgery

The primary objective was to compare the efficacy 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 hip fracture surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing hip fracture surgery, and to document AVE5026 exposure in this population.

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Key information

Conditions

Venous Thromboembolism Cardiovascular Diseases Embolism and Thrombosis Femoral Fractures Fractures, Bone Hip Fractures Hip Injuries Leg Injuries Thromboembolism Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis Administrative Office, Buenos Aires, Argentina

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About this study

Randomization had to take place just prior to the first study drug injection (randomization ratio 1:1).

The total duration of observation per participant was 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 had to be performed between 7 to 11 days after surgery.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Standard surgery for fracture of the upper third of the femur including femoral head and neck.

Exclusion criteria

  • Estimated time of injury/fracture > 24 hours before admission to hospital;
  • Any major orthopedic surgery in the 3 months prior to study start;
  • Multiple trauma affecting more than one organ system;
  • Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
  • High risk of bleeding;
  • Known allergy to heparin, or enoxaparin, or pork products;
  • End stage renal disease or patient on dialysis;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Treatment and study plan

Enoxaparin sodium

Drug

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

Subcutaneous injection

Other names: Lovenox®

Semuloparin sodium

Drug

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

Subcutaneous injection

Other names: AVE5026

Placebo

Drug

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance but without active component

Subcutaneous injection

Primary outcomes

  1. Percentage of Participants Who Experienced 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 came first

    VTE included any Deep Vein Thrombosis [DVT] (proximal or distal, 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 included fatal PE and deaths for other reason than PE.

Secondary outcomes

  1. Percentage of Participants Who Experienced "Major" VTE or All-cause Death

    Time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first

    "major" VTE included any proximal DVT, symptomatic distal DVT and non-fatal PE as confirmed by the CIAC.

  2. Percentage of Participants Who Experienced Clinically Relevant Bleedings

    Time frame: From first study drug injection up to 3 days after last study drug injection

    Bleedings were 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 healthcare professional);
    • "Non-clinically relevant bleeding".

  3. Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment

    Time frame: From randomization up to 10 days after surgery or the day of mandatory venography, whichever came 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.

Other outcomes

  1. Overview of deaths

    Time frame: From first study drug injection up to 3 days after last study drug injection

    All deaths were centrally and blindly reviewed by the CIAC and classified as fatal PE, fatal bleeding, cardiovascular death or other based on relevant documentation (e.g. autopsy report).

  2. Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]

    Time frame: From first study drug injection up to 3 days after last study drug injection

    PCSA are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review.

    Threshold for platelet counts was defined as <100 Giga/L.

  3. Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA]

    Time frame: From first study drug injection up to 3 days after last study drug injection

    Thresholds were defined as follows:

    • Alanine Aminotransferase [ALAT] >3 Upper Normal Limit [ULN];
    • Total Bilirubin [TB] >2 ULN;
    • ALAT >3 ULN and TB >2 ULN;

    Cases with ALAT >3 ULN and TB >2 ULN (not necessarily concomitant) were evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria.

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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 Hip Fracture Surgery

Acronym: SAVE-HIP2

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 24, 2008
Registry last updated
Jan 23, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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