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

NCT01356329 | Suspended Phase 3

• 1 other identifier: RC08/118
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Female Reproductive System Neoplasm

Keywords

Gynecologic malignancy ,major surgery

Outcome Measures

Primary Outcomes (1)

• Safety

  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.

  3 years

Secondary Outcomes (1)

• Safety

  3 years

Study Arms (2)

Lovenox

EXPERIMENTAL

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

Drug: Enoxaparin, Heparin

Heparin

EXPERIMENTAL

Group B:HeparinTM (Unfractionated Heparin)

Drug: Enoxaparin, Heparin

Interventions

Enoxaparin, Heparin 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; Lovenox

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cancer patients aged 18 years or older were admitted with diagnosis of malignancy or suspension of malignancy and going for major surgery.
• Patient with the following conditions:
• Any patient were admitted with diagnosis of Gynecologic malignancy \& going for major surgery such as laparotomies \& abdominal hysterectomy OR
• 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
• Signed the Informed Consent Form

You may not qualify if:

• 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

Sponsors & Collaborators

• National Guard Health Affairs: lead

Study Sites (1)

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

Location

MeSH Terms

Interventions

Enoxaparin; Heparin

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-Weight; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Faisal Safi, MD

  King Abdul Aziz Medical City for National Guard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2011
• First Posted: May 19, 2011
• Study Start: October 1, 2009
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

SA (1)