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.

Eurofarma Laboratorios S.A.5 sites in 1 country544 target enrollmentOctober 2011

ConditionsHip Fracture Surgery

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Hip Fracture Surgery
Sponsor: Eurofarma Laboratorios S.A.
Enrollment: 544
Locations: 5
Primary Endpoint: The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).
Status: Terminated
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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).

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

October 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eurofarma Laboratorios S.A.

Responsible Party

Sponsor

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);