NCT01356329

Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients

A Randomized, Controlled, Open Label Study of the Efficacy and Safety of the Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin) Versus HeparinTM (Unfractionated Heparin) for Prevention of Venous Thromboembolism (VTE) in Gynecologic Oncology Patients

• Status: Suspended
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National Guard Health Affairs · Other Government
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prophylactic treatment will start from surgery until the patients are discharged from the hospital(18). Then each patient will have 2 follow up visit in gyne- oncology clinic. The first visit will be 2 weeks from discharge \& the second visit will be 3 months after surgery. In each visit patient will be evaluated for any evidence of thrombo-embolic events clinically \& radiologically if needed ( spiral CT, V/Q scan \& lower limp Doppler ). Any side effect or adverse reaction will be reported \& it will be evaluated if it is related to the drug used or not.

Detailed description

This study is a phase IIIB, randomized, open label, non-comparative controlled trial, and prospectively enrolling 150 females to assess the efficacy and safety of the Enoxaparin (Group A) and Unfractionated Heparin (Group B) for Gynecologic Oncology Patients In the Kingdom of Saudi Arabia who required surgery or admission for the prevention of VTE. Patients who meet the Inclusion Criteria and signed an informed consent will be randomly assigned to 1 of the 2 treatment groups (Group A or Group B). Subjects will be assigned consecutive study numbers according to a predetermined random code generated by the Biostatistician. The randomisation will be based on a 1:1 ratio.

Conditions

• Malignant Female Reproductive System Neoplasm

Interventions

Type	Name	Description
DRUG	Enoxaparin, Heparin	Patients who meet the Inclusion Criteria and signed an informed consent will be randomly assigned to 1 of the 2 treatment groups (the Enoxaparin (Group A) and Unfractionated Heparin (Group B) ). Subjects will be assigned consecutive study numbers according to a predetermined random code generated by the Biostatistician.

Timeline

• Start date: 2009-10-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2011-05-19
• Last updated: 2016-05-13

Locations

1 site across 1 country: Saudi Arabia