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

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Eurofarma

Status and phase

Terminated
Phase 3

Conditions

Hip Fracture Surgery

Treatments

Biological: Heparin Sodium - Eurofarma
Biological: Heparin Sodium - APP Pharmaceuticals

Study type

Interventional

Funder types

Industry

Identifiers

NCT01352039
EF098 - HEP-SC

Details and patient eligibility

About

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.

Full 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).

Enrollment

544 patients

Sex

All

Ages

60 to 85 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

544 participants in 2 patient groups

Heparin Sodium - Eurofarma
Experimental group
Treatment:
Biological: Heparin Sodium - Eurofarma
Heparin Sodium - APP Pharmaceuticals
Active Comparator group
Treatment:
Biological: Heparin Sodium - APP Pharmaceuticals

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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