Overview

This trial is active, not recruiting.

Condition venous thromboembolism
Treatments heparin sodium - hipolabor, heparin sodium - app
Phase phase 2/phase 3
Sponsor L.A.L Clinica Pesquisa e Desenvolvimento Ltda.
Start date May 2010
End date November 2010
Trial size 140 participants
Trial identifier NCT00934167, HEPHIP0509_PRO, JAN. 2010, Version 01 - AMENDMENT 01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Hipolabor
heparin sodium - hipolabor
5.000 UI/0,25mL
(Active Comparator)
5.000 USP/mL - APP
heparin sodium - app
5.000 USP/mL

Primary Outcomes

Measure
Non-appearance of venous thromboembolism
time frame: 2 h before the start of surgery, 1, 2, 3, 4, 5, 6, 7, 14, 21, 28 days

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: - 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 Criteria: - 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.

Additional Information

Official title 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2010.
Information provided to ClinicalTrials.gov by L.A.L Clinica Pesquisa e Desenvolvimento Ltda..