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

NCT01352039 | Terminated Phase 3 DMC

• 1 other identifier: EF098 - HEP-SC
• Study Type: interventional
• Target: 544
• Locations: 1 country
• Sites: 5

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.

Conditions

Hip Fracture Surgery

Keywords

Heparin Sodium; Thromboprophylaxis; Hip Fracture Surgery.

Outcome Measures

Primary Outcomes (1)

• The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).

  6 months

Secondary Outcomes (1)

• The Secundary endpoint will be proximal and distal DVT

  6 months

Study Arms (2)

Heparin Sodium - Eurofarma

EXPERIMENTAL

Biological: Heparin Sodium - Eurofarma

Heparin Sodium - APP Pharmaceuticals

ACTIVE COMPARATOR

Biological: Heparin Sodium - APP Pharmaceuticals

Interventions

Heparin Sodium - Eurofarma BIOLOGICAL

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

Heparin Sodium - Eurofarma

Heparin Sodium - APP Pharmaceuticals BIOLOGICAL

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

Heparin Sodium - APP Pharmaceuticals

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eurofarma Laboratorios S.A.: lead

Study Sites (5)

Santa Casa de Misericórdia de Belo Horizonte

Belo Horizonte, Minas Gerais, 30150221, Brazil

Location

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

Juiz de Fora, Minas Gerais, 36021-630, Brazil

Location

Associação Hospitalar Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Irmandade Santa Casa de Misericórdia de Marília

Marília, São Paulo, 17515-900, Brazil

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 11, 2011
• Study Start: October 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2012
• Last Updated: October 16, 2012

Record last verified: 2012-10

Locations

BR (5)