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

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 (SAVE HIP 2)

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000460

Enrollment

1000

Registered

2009-07-21

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I824- Acute embolism and thrombosis of deep veins of lower extremity Health Condition 2: null- Venous Thromboembolsim

Interventions

Intervention1: AVE5026: once daily subcutaneous injection for 7 to 10 days after surgery Control Intervention1: Enoxaparin: once daily subcutaneous injection for 7 to 10 days after surgery

Eligibility

Inclusion criteria

Inclusion criteria: - Standard surgery for fracture of the upper third of the femur including femoral head and neck.

Exclusion criteria

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 - Patients at high risk of bleeding - Known allergy to heparin, or enoxaparin, or pork products

Design outcomes

Primary

Measure	Time frame
A composite of any VTE confirmed by a blinded Central Independent Adjudication Committee (CIAC), and deaths from any cause reported during the efficacy evaluation period.Timepoint: From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first	—

Secondary

Measure	Time frame
Any proximal DVT, symptomatic distal DVT, non fatal PE, and all cause deaths. A symptomatic distal DVT will be defined as distal DVT confirmed by appropriate diagnostic tests and associated with consistent signs and symptoms of VTE. A systematic screening for signs and symptoms of VTE will be performed prior to any diagnostic tests for VTE. ? Initiation of curative anticoagulant or thrombolytic treatment by the investigator after local VTE assessment" Timepoint: From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first	—

Measure

Time frame

Any proximal DVT, symptomatic distal DVT, non fatal PE, and all cause deaths. A symptomatic distal DVT will be defined as distal DVT confirmed by appropriate diagnostic tests and associated with consistent signs and symptoms of VTE. A systematic screening for signs and symptoms of VTE will be performed prior to any diagnostic tests for VTE. ? Initiation of curative anticoagulant or thrombolytic treatment by the investigator after local VTE assessment" Timepoint: From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first

—

Countries

India

Contacts

Public ContactDr Josemund Menezes

Josemund.Menezes@sanofi-aventis.com022-28278024

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026