Symptoms and General Pathology

All Conditions

Heart and Blood Diseases

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Body Weight

Thromboembolism

Venous Thromboembolism

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Fibrinolytic Agents

Anticoagulants

All Drugs and Chemicals

Heparin

Enoxaparin

Calcium heparin

Heparin, Low-Molecular-Weight

Tinzaparin

Dalteparin

Enoxaparin sodium

Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)

Group B:HeparinTM (Unfractionated 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.

Enoxaparin, Heparin

Faisal Safi, MD

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.

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.

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

Efficacy will be measured by measuring any thromboembolic events confirmed by objective testing such as spiral CT or V/Q scan and Doppler ultrasound as well as coagulation profile parameter, clinical sign and symptoms within 3 months post-operation.

•To evaluate the Number of participants with Adverse Events and Serious Adverse Events of both treatment groups.

Safety will include the following parameters for all patients who receive the study regimen:

* Time to thromboembolic event
* Total number of deaths from any cause
* Proportion of patients with major bleeding
* Site of thromboembolic event
* Overall survival

National Guard Health Affairs

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients	NCT01356329	Malignant Femal...	Enoxaparin, Hep...	18 Years -	National Guard Health Affairs
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients	NCT01356329	Malignant Femal...	Enoxaparin, Hep...	18 Years -	National Guard Health Affairs
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients	NCT01356329	Malignant Femal...	Enoxaparin, Hep...	18 Years -	National Guard Health Affairs

Spots Global Cancer Trial Database for enoxaparin, heparin