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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01352039
First received: May 10, 2011
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Hip Fracture Surgery
Biological: Heparin Sodium - Eurofarma
Biological: Heparin Sodium - APP Pharmaceuticals
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS). [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The Secundary endpoint will be proximal and distal DVT [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 544
Study Start Date: October 2011
Study Completion Date: October 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   60 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01352039

Locations
Brazil
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150221
Centro de Pesquisa Clínica da Santa Casa de Misericórida de Juíz de Fora
Juiz de Fora, Minas Gerais, Brazil, 36021-630
Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
Associação Hospitalar Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil, 90035-001
Irmandade Santa Casa de Misericórdia de Marília
Marília, São Paulo, Brazil, 17515-900
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01352039     History of Changes
Other Study ID Numbers: EF098 - HEP-SC
Study First Received: May 10, 2011
Last Updated: October 15, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Eurofarma Laboratorios S.A.:
Heparin Sodium
Thromboprophylaxis
Hip Fracture Surgery.

Additional relevant MeSH terms:
Fractures, Bone
Hip Fractures
Wounds and Injuries
Femoral Fractures
Hip Injuries
Leg Injuries
Calcium heparin
Heparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on October 01, 2014