Status:

WITHDRAWN

Efficacy of Sodium Heparin in Prophylaxis of Venous Thromboembolism in Surgical Patients

Lead Sponsor:

Azidus Brasil

Conditions:

Venous Thromboembolism

Eligibility:

All Genders

18-60 years

Phase:

PHASE3

Brief Summary

The Venous thromboembolism (VTE) disease is very frequent, mainly as complications of medical diseases and surgical procedures. It has high prevalence and can lead to severe complications such as pulm...

Eligibility Criteria

Inclusion

  • Accept all items described in Informed Consent, signing it in two ways;
  • Age between 40 and 60 years without additional risk factors, which held more surgery (general, gynecological and urological);
  • Women aged 18 to 40 years making use of estrogen;
  • Be alert to the need for surgery antithrombotic prophylaxis;
  • Be classified as "moderate risk" for developing VTE, according to the protocol of prophylaxis of deep vein thrombosis of the Brazilian Society of Angiology and Vascular Surgery.

Exclusion

  • Acute coronary syndrome;
  • Immobilization of the lower limbs due to fractures, because in this way will be considered as high risk;
  • history of recent stroke;
  • Patients at high risk of bleeding in which the use of heparin is contra-indicated;
  • General Surgery in patients over 60 years in the case of patients at high risk for VTE;
  • general surgery in patients 40 to 60 years with additional risk factors for development of VTE;
  • Major amputations;
  • more orthopedic surgeries;
  • Patients with pre-surgical diagnosis of malignant neoplasms;
  • Patients with a platelet level below 100x109 / L;
  • Use of anticoagulants 48 hours before randomization;
  • severe liver failure;
  • Be classified as "Low Risk" or "high risk" for developing VTE
  • Pregnancy and lactation.

Key Trial Info

Start Date :

May 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2011

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00912483

Start Date

May 1 2010

End Date

January 1 2011

Last Update

March 29 2013

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