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

NCT ID: NCT01356329

Last Updated: 2016-05-13

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: PHASE3
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2016-08-31

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.

Conditions

Malignant Female Reproductive System Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Lovenox

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

Group Type: EXPERIMENTAL

Enoxaparin, Heparin

Intervention Type: DRUG

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.

Heparin

Group B:HeparinTM (Unfractionated Heparin)

Group Type: EXPERIMENTAL

Enoxaparin, Heparin

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Guard Health Affairs

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Faisal Safi, MD

Role: PRINCIPAL_INVESTIGATOR

King Abdul Aziz Medical City for National Guard

Locations

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, , Saudi Arabia

Countries

Saudi Arabia

Other Identifiers

RC08/118

Identifier Type: -

Identifier Source: org_study_id