Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients (Lovenox)
Primary Purpose
Malignant Female Reproductive System Neoplasm
Status
Suspended
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Enoxaparin, Heparin
Sponsored by
About this trial
This is an interventional prevention trial for Malignant Female Reproductive System Neoplasm focused on measuring Gynecologic malignancy ,major surgery
Eligibility Criteria
Inclusion Criteria:
- Cancer patients aged 18 years or older were admitted with diagnosis of malignancy or suspension of malignancy and going for major surgery.
Patient with the following conditions:
- Any patient were admitted with diagnosis of Gynecologic malignancy & going for major surgery such as laparotomies & abdominal hysterectomy OR
- 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
- 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
Sites / Locations
- King Abdul Aziz Medical City for National Guard Health Affairs
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lovenox
Heparin
Arm Description
Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)
Group B:HeparinTM (Unfractionated Heparin)
Outcomes
Primary Outcome Measures
Safety
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.
Secondary Outcome Measures
Safety
•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
Full Information
NCT ID
NCT01356329
First Posted
March 19, 2011
Last Updated
May 12, 2016
Sponsor
National Guard Health Affairs
1. Study Identification
Unique Protocol Identification Number
NCT01356329
Brief Title
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients
Acronym
Lovenox
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Suspended
Why Stopped
Difficulty in enrolling patients
Study Start Date
October 2009 (undefined)
Primary Completion Date
August 2016 (Anticipated)
Study Completion Date
August 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Guard Health Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Female Reproductive System Neoplasm
Keywords
Gynecologic malignancy ,major surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lovenox
Arm Type
Experimental
Arm Description
Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)
Arm Title
Heparin
Arm Type
Experimental
Arm Description
Group B:HeparinTM (Unfractionated Heparin)
Intervention Type
Drug
Intervention Name(s)
Enoxaparin, Heparin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Safety
Description
•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
Time Frame
3 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cancer patients aged 18 years or older were admitted with diagnosis of malignancy or suspension of malignancy and going for major surgery.
Patient with the following conditions:
Any patient were admitted with diagnosis of Gynecologic malignancy & going for major surgery such as laparotomies & abdominal hysterectomy OR
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faisal Safi, MD
Organizational Affiliation
King Abdul Aziz Medical City for National Guard
Official's Role
Principal Investigator
Facility Information:
Facility Name
King Abdul Aziz Medical City for National Guard Health Affairs
City
Riyadh
ZIP/Postal Code
11426
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients
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