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

Phase 3

Terminated

• Conditions: Hip Fracture Surgery
• Interventions: Biological: Heparin Sodium - Eurofarma; Biological: Heparin Sodium - APP Pharmaceuticals

• Registration Number: NCT01352039
• Lead Sponsor: Eurofarma Laboratorios S.A.

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).

Study Timeline

• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Study Start: 2011-10
• Primary Completion: 2011-10
• Status Verified: 2012-10
• Study Completion: 2012-10
• Last Update Submitted: 2012-10-15
• Last Update Posted: 2012-10-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 544

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Heparin Sodium - Eurofarma	Heparin Sodium - Eurofarma	-
Heparin Sodium - APP Pharmaceuticals	Heparin Sodium - APP Pharmaceuticals	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Secundary endpoint will be proximal and distal DVT	6 months

Trial Locations

Locations (5)

Irmandade Santa Casa de Misericórdia de Marília; 🇧🇷 Marília, São Paulo, Brazil

Santa Casa de Misericórdia de Belo Horizonte; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil

Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul; 🇧🇷 Porto Alegre, Rio Grande do Sul, 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