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

This study is currently recruiting participants.
Verified October 2012 by National Guard Health Affairs
Sponsor:
Information provided by (Responsible Party):
National Guard Health Affairs
ClinicalTrials.gov Identifier:
NCT01356329
First received: March 19, 2011
Last updated: October 20, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Malignant Female Reproductive System Neoplasm
 Drug: Enoxaparin, Heparin
 Phase 3

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Guard Health Affairs:

Primary Outcome Measures:
  • Safety [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

    •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


Estimated Enrollment: 150
Study Start Date: October 2009
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lovenox
Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)
 Drug: 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.
Experimental: Heparin
Group B:HeparinTM (Unfractionated Heparin)
 Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01356329

Contacts
Contact: Faisal Safi, MD Gynecology 0096612520088 ext 14107 safif@ngha.med.sa
Contact: Oncology Research 0096612520088 ext 14601 oncologyresearch@ngha.med.sa

Locations
Saudi Arabia
King Abdul Aziz Medical City for National Guard Health Affairs Recruiting
Riyadh, Saudi Arabia, 11426
Contact: Faisal Safi, MD     0096612520088 ext 14107     safif@ngha.med.sa    
Contact: Oncology Research     0096612520088 ext 14601     oncologyresearch@ngha.med.sa    
Principal Investigator: Faisal Safi, MD            
Sponsors and Collaborators
National Guard Health Affairs
Investigators
Principal Investigator: Faisal Safi, MD King Abdul Aziz Medical City for National Guard
  More Information

No publications provided

Responsible Party: National Guard Health Affairs
ClinicalTrials.gov Identifier: NCT01356329     History of Changes
Other Study ID Numbers: RC08/118
Study First Received: March 19, 2011
Last Updated: October 20, 2012
Health Authority: Saudi Arabia: Ethics Committee

Keywords provided by National Guard Health Affairs:
Gynecologic malignancy ,major surgery

Additional relevant MeSH terms:
Neoplasms
Genital Neoplasms, Female
Venous Thromboembolism
Urogenital Neoplasms
Neoplasms by Site
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Calcium heparin
Heparin
 Heparin, Low-Molecular-Weight
Dalteparin
Enoxaparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 21, 2013