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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

About this trial

This is an interventional prevention trial for Malignant Female Reproductive System Neoplasm focused on measuring Gynecologic malignancy ,major surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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:
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
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

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

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

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Safety

Description

Time Frame

3 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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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