A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery

NCT ID: NCT01352039

Last Updated: 2012-10-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 544 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-10-31

Brief Summary

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.

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).

Conditions

Hip Fracture Surgery

Keywords

Heparin Sodium; Thromboprophylaxis; Hip Fracture Surgery.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Heparin Sodium - Eurofarma

Group Type: EXPERIMENTAL

Heparin Sodium - Eurofarma

Intervention Type: BIOLOGICAL

Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

Heparin Sodium - APP Pharmaceuticals

Group Type: ACTIVE_COMPARATOR

Heparin Sodium - APP Pharmaceuticals

Intervention Type: BIOLOGICAL

Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

Interventions

Heparin Sodium - Eurofarma

Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

Intervention Type: BIOLOGICAL

Heparin Sodium - APP Pharmaceuticals

Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Centro de Pesquisa Clínica da Santa Casa de Misericórida de Juíz de Fora

Juiz de Fora, Minas Gerais, Brazil

Associação Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Irmandade Santa Casa de Misericórdia de Marília

Marília, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF098 - HEP-SC

Identifier Type: -

Identifier Source: org_study_id