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

• Status: Suspended
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Guard Health Affairs
• Treatments: Calcium heparin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight

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