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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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Malignant Female Reproductive System Neoplasm

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Trial Information

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


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.


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. Any patient were admitted with diagnosis of Gynecologic malignancy & going for major
surgery such as laparotomies & abdominal hysterectomy

3. 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

4. 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Safety

Outcome 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.

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Faisal Safi, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

King Abdul Aziz Medical City for National Guard

Authority:

Saudi Arabia: Ethics Committee

Study ID:

RC08/118

NCT ID:

NCT01356329

Start Date:

October 2009

Completion Date:

October 2012

Related Keywords:

  • Malignant Female Reproductive System Neoplasm
  • Gynecologic malignancy ,major surgery
  • Neoplasms
  • Genital Neoplasms, Female
  • Venous Thromboembolism

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