Efficacy of Sodium Heparin for Prophylaxis of Venous Thromboembolism in Surgical Patients
NON CLINICAL INFERIORITY OF HEPARIN SODIUM PRODUCED BY HIPOLABOR FARMACEUTICA LTDA COMPARED TO THE HEPARIN SODIUM PRODUCED BY APP PHARMACEUTICALS IN VENOUS THROMBOEMBOLISM PROPHYLAXIS, IN SURGICAL PATIENTS WITH MEDIUM RISK FOR DEVELOPMENT OF THROMBOEMBOLISM.
3 other identifiers
interventional
140
1 country
1
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 (heparin sodium 5.000USP/mL - APP) in preventing the development of venous thromboembolism (VTE) in patients undergoing surgery for medium risk for the development of this pathology.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2009
CompletedFirst Posted
Study publicly available on registry
July 8, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedOctober 27, 2010
February 1, 2010
6 months
July 6, 2009
October 26, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Non-appearance of venous thromboembolism
2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days
Study Arms (2)
Test
EXPERIMENTALHipolabor
Comparator
ACTIVE COMPARATOR5.000 USP/mL - APP
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azidus Brasillead
Study Sites (1)
Lal Clinica Pesquisa E Desenvolvimento Ltda
Valinhos, São Paulo, 13270000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
July 6, 2009
First Posted
July 8, 2009
Study Start
May 1, 2010
Primary Completion
November 1, 2010
Study Completion
September 1, 2011
Last Updated
October 27, 2010
Record last verified: 2010-02