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Difficulty in enrolling patients
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lovenox | Experimental | Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin) |
|
| Heparin | Experimental | Group B:HeparinTM (Unfractionated Heparin) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | •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:
| 3 years |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Faisal Safi, MD | King Abdul Aziz Medical City for National Guard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King Abdul Aziz Medical City for National Guard Health Affairs | Riyadh | 11426 | Saudi Arabia |
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| ID | Term |
|---|---|
| D017984 | Enoxaparin |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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