A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery (HEP-SC)

A Phase III, Non-inferiority, Randomized, Double-blind Trial Comparing Eurofarma Unfractionated Sodium Heparin 5,000 IU to APP Pharmaceuticals Unfractionated Sodium Heparin 5,000 IU in the Thromboprophylaxis of Geriatric Patients Who Underwent Hip Fracture Surgery.

The primary objective and endpoints of the study is compare the efficacy of two products containing heparin sodium, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.

Study Overview

• Status: Terminated
• Conditions: Hip Fracture Surgery
• Intervention / Treatment: Biological: Heparin Sodium - Eurofarma; Biological: Heparin Sodium - APP Pharmaceuticals

Detailed Description

The primary objective of the study is to assess the efficacy of unfractionated heparin sodium of porcine origin (Eurofarma) in the prophylaxis of VTE relative to unfractionated heparin sodium of porcine origin from APP Pharmaceuticals. The primary endpoint will be the frequency of DVT determined by Doppler ultrasound (DUS).

• Study Type: Interventional
• Enrollment (Actual): 544
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil, 30150221
      • Santa Casa de Misericórdia de Belo Horizonte
    • Juiz de Fora, Minas Gerais, Brazil, 36021-630
      • Centro de Pesquisa Clínica da Santa Casa de Misericórida de Juíz de Fora
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
      • Associacao Hospitalar Moinhos de Vento
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul
  • São Paulo
    • Marília, São Paulo, Brazil, 17515-900
      • Irmandade Santa Casa de Misericórdia de Marília

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

In order to be enrolled in this study, eligible patients must meet all criteria below:

• ICF signing;
• Aged 60 to 85 years old;
• Indication of hip orthopedic surgery due to fracture occurred within the last 5 days;
• Normal coagulation profile or with alterations up to 25% of normal values.

Exclusion Criteria:

Patients who meet any of the following criteria will not be eligible for the study:

• Previous hip surgery;
• Fracture secondary to the presence of metastasis;
• Recent traumatic brain, thoracic, or abdominal injury (up to 30 days before study start);
• Recent occurrence (up to 30 days before study start) of cerebrovascular accident;
• Serum concentration of hemoglobin below 9 g/dL;
• Prior occurrence (in the last 5 years) of confirmed or suspected thromboembolic event;
• Occurrence of major bleeding in the last 6 months (any spontaneous gastrointestinal bleeding; central nervous system bleeding; massive epistaxis, or gum bleeding; gross hematuria, or vaginal bleeding);
• Confirmed or suspected blood dyscrasia;
• Diagnosis of neoplasm other than in situ in the last 24 months or any active neoplasm (neoplasms in situ do not prevent patient from participating);
• Liver or kidney failure;
• Clinically significant gastrointestinal cardiovascular, neurological disease, or laboratory abnormalities, which at the investigator's opinion, may interfere with individual's participation in the study or with assessment of individual's response to treatment;
• Hypersensitivity to heparin;
• Previous use (15 days before study start) of oral anticoagulants or expected use during the study (see Appendix B);
• Recent participation (previous 12 months) in a clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Heparin Sodium - Eurofarma	Biological: Heparin Sodium - Eurofarma; Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
Active Comparator: Heparin Sodium - APP Pharmaceuticals	Biological: Heparin Sodium - APP Pharmaceuticals; Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The Secundary endpoint will be proximal and distal DVT	6 months

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: May 10, 2011
• First Submitted That Met QC Criteria: May 10, 2011
• First Posted (Estimate): May 11, 2011

Study Record Updates

• Last Update Posted (Estimate): October 16, 2012
• Last Update Submitted That Met QC Criteria: October 15, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Heparin Sodium; Thromboprophylaxis; Hip Fracture Surgery.
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Hip Injuries; Fractures, Bone; Hip Fractures; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: EF098 - HEP-SC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No