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

Phase 3

Suspended

• Conditions: Malignant Female Reproductive System Neoplasm
• Interventions: Drug: Enoxaparin, Heparin

• Registration Number: NCT01356329
• Lead Sponsor: National Guard Health Affairs

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.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-03-19
• Study First Submitted QC: 2011-05-17
• Study First Posted: 2011-05-19
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-12
• Last Update Posted: 2016-05-13
• Primary Completion: 2016-08
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: Female
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lovenox	Enoxaparin, Heparin	Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)
Heparin	Enoxaparin, Heparin	Group B:HeparinTM (Unfractionated Heparin)

Primary Outcome Measures

Name	Time	Method
Safety	3 years	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

Name	Time	Method
Safety	3 years	•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

Trial Locations

Locations (1)

King Abdul Aziz Medical City for National Guard Health Affairs; 🇸🇦 Riyadh, Saudi Arabia