Clinical trial NCT01352039: A Non-inferiority Study Comparing Two Heparin Sodium Preparations in Hip Fracture Surgery
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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hip Fracture Surgery
Keywords: Heparin Sodium
Thromboprophylaxis
Hip Fracture Surgery.
Lead sponsor: Eurofarma Laboratorios S.A.
Sponsor class: INDUSTRY
First posted: 2011-05-11
Enrollment: 544
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).

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.

Primary outcomes:
measure: The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).
timeFrame: 6 months
Secondary outcomes:
measure: The Secundary endpoint will be proximal and distal DVT
timeFrame: 6 months
Other outcomes:
Locations:
city: Belo Horizonte
country: Brazil
facility: Santa Casa de Misericórdia de Belo Horizonte
state: Minas Gerais
city: Juiz de Fora
country: Brazil
facility: Centro de Pesquisa Clínica da Santa Casa de Misericórida de Juíz de Fora
state: Minas Gerais
city: Porto Alegre
country: Brazil
facility: Associação Hospitalar Moinhos de Vento
state: Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul
state: Rio Grande do Sul
city: Marília
country: Brazil
facility: Irmandade Santa Casa de Misericórdia de Marília
state: São Paulo
Study officials:
References: