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

Hip Fracture Surgery Clinical Trial

— HEP-SC  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01352039
• Other study ID #: EF098 - HEP-SC
• Status: Terminated
• Phase: Phase 3
• First received: May 10, 2011
• Last updated: October 15, 2012
• Start date: October 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 544
• Est. completion date: October 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fracture Surgery
• Hip Fractures

Intervention

Biological:
• Heparin Sodium - Eurofarma
Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
• Heparin Sodium - APP Pharmaceuticals
Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI

Locations

Country	Name	City	State
Brazil	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	Irmandade Santa Casa de Misericórdia de Marília	Marília	São Paulo
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

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).		6 months	Yes
Secondary	The Secundary endpoint will be proximal and distal DVT		6 months	Yes