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

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.

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01352039

Acronym

HEP-SC

Enrollment

544

Registered

2011-05-11

Start date

2011-10-31

Completion date

2012-10-31

Last updated

2012-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Fracture Surgery

Keywords

Heparin Sodium, Thromboprophylaxis, Hip Fracture Surgery.

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).

Interventions

BIOLOGICALHeparin Sodium - Eurofarma

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

BIOLOGICALHeparin Sodium - APP Pharmaceuticals

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

60 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
The Primary endpoint will be frequency of deep venous thrombosis (DVT) determined by Doppler ultrasound (DUS).	6 months

Secondary

Measure	Time frame
The Secundary endpoint will be proximal and distal DVT	6 months

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026