Clinical trial · Interventional
Efficacy and Safety of the LovenoxTM (Enoxaparin) Versus HeparinTM Gynecologic Oncology Patients
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in enrolling patients
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Female Reproductive System Neoplasm | Malignant Female Reproductive System Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enoxaparin, Heparin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lovenox
- description
- Group A : Low Molecular Weight Heparin (LMWH), LovenoxTM (Enoxaparin)
- interventionNames
- Drug: Enoxaparin, Heparin
- type
- EXPERIMENTAL
- label
- Heparin
- description
- Group B:HeparinTM (Unfractionated Heparin)
- interventionNames
- Drug: Enoxaparin, Heparin
Primary outcomes (1)
- measure
- Safety
- timeFrame
- 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available