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.

Status

UNKNOWN

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00934167

Enrollment

140

Registered

2009-07-08

Start date

2010-05-31

Completion date

2011-09-30

Last updated

2010-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

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.

Interventions

BIOLOGICALheparin sodium - Hipolabor

5.000 UI/0,25mL

BIOLOGICALHeparin sodium - APP

5.000 USP/mL

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026