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

May 12, 2016 updated by: National Guard Health Affairs

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11426
        • King Abdul Aziz Medical City for National Guard Health Affairs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Cancer patients aged 18 years or older were admitted with diagnosis of malignancy or suspension of malignancy and going for major surgery.

  2. Patient with the following conditions:

    1. Any patient were admitted with diagnosis of Gynecologic malignancy & going for major surgery such as laparotomies & abdominal hysterectomy OR
    2. All staging laparotomies done for suspected ovarian malignancy by either ultrasound finding or tumor markers (raised CA 125) & found to be either borderline or benign ovarian tumor
  3. Signed the Informed Consent Form

Exclusion Criteria:

1 Renal failure assessed by serum creatinine > 2.0mg/dL (180 mmol/L) 2. Patients on anticoagulant treatment in the previous 6 months 3. Bleeding disorders or platelet count < 80x109/L 4. Known hypersensitivity to unfractionated heparin or LMWHs 5. Pregnant women 6. Obese patients with body mass index ≥ 47

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lovenox
Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)
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.
Experimental: Heparin
Group B:HeparinTM (Unfractionated Heparin)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 3 years
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 3 years

•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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Guard Health Affairs

Investigators

  • Principal Investigator: Faisal Safi, MD, King Abdul Aziz Medical City for National Guard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

August 1, 2016

Study Completion (Anticipated)

August 1, 2016

Study Registration Dates

First Submitted

March 19, 2011

First Submitted That Met QC Criteria

May 17, 2011

First Posted (Estimate)

May 19, 2011

Study Record Updates

Last Update Posted (Estimate)

May 13, 2016

Last Update Submitted That Met QC Criteria

May 12, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC08/118

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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