Clinical trial · Interventional
Japanese Efficacy and Safety Study of Enoxaparin in Patients With Curative Abdominal Cancer Surgery
Multicenter, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Enoxaparin Sodium (RP54563) 20mg Bid for 14 Days for Prevention of Venous Thromboembolism in Patients With Curative Abdominal Cancer Surgery. Physical Prophylaxis Only Arm [Intermittent Pneumatic Compression (IPC)] Will be Used as an Indicator of Event Rates.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The primary objective of this study is to evaluate the effects of enoxaparin on venous thromboembolism incidence and bleeding rate (major and minor bleeding) in patients undergoing curative abdominal cancer surgery. The secondary objective is evaluate the incidence of adverse events of enoxaparin in these patients.
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 |
|---|---|---|---|
| Abdominal Neoplasms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| enoxaparin | Drug | — | UNRESOLVED |
| Physical prophylaxis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- 1
- description
- Enoxaparin
- interventionNames
- Drug: enoxaparin
- type
- OTHER
- label
- 2
- description
- Intermittent Pneumatic Compression (IPC)
- interventionNames
- Other: Physical prophylaxis
Primary outcomes (1)
- measure
- Venous thromboembolism incidence
- timeFrame
- 28 days
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Malignant tumor patients undergoing laparotomy for which surgery is expected to take 45 minutes or more. Exclusion Criteria: * surgery under laparoscope and other endoscopic operations * clinical signs of deep vein thrombosis * use of non-steroidal anti-inflammatory drugs from surgery completion until initial administration * severe hepatic disease or renal disease * women of childbearing potential, pregnant or lactating.
References
Publications (0)
Data not yet available