Status:
UNKNOWN
Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients
Lead Sponsor:
Azidus Brasil
Conditions:
Venous Thromboembolism
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
The aim of this study is to verify, through clinical examination and doppler, the non-inferiority of the drug test (heparin sodium 5.000UI/0.25 mL - HIPOLABOR) in relation to the drug compared (hepari...
Eligibility Criteria
Inclusion
- Accept all items described in IC signing it in two ways;
- Be aged between 18 and 60;
- 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, it will make use of anticoagulation;
- 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, according to Maffei et al. (2005);
- Pregnancy and lactation.
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00934167
Start Date
May 1 2010
End Date
September 1 2011
Last Update
October 27 2010
Active Locations (1)
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1
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, Brazil, 13270000