Clinical trial · Interventional
Thromboprophylaxis in Oesophageal Cancer Patients
Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial
NCT05067153CI-TRIAL-00054260TOP-RCTunknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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 purpose of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Thromboembolism | — | UNRESOLVED | — |
| Thrombosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fragmin 5000 UNT in 0.2 ML Prefilled Syringe | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily.
- interventionNames
- Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe
- type
- ACTIVE_COMPARATOR
- label
- Control
- description
- Control group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily.
- interventionNames
- Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe
Primary outcomes (1)
- measure
- Prothrombin fragment F1+2
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cancer located in oesophagus and/or cardia. 2. Candidate for intended curative surgery. 3. Age \> 18 years. Exclusion Criteria: 1. Known inherited bleeding disorder. 2. Unable to provide informed consent. 3. Arterial or venous thromboembolic events within the last three months. 4. On-going anticoagulant treatment (Vitamin K antagonists or direct oral anticoagulants). 5. Pregnant or has given birth within the last three months. 6. Known allergy to the trial drug Dalteparin (Fragmin®).
References
Publications (2)
- DERIVEDGyldenholm T, Madsen N, Katballe N, Kjaer DW, Christensen TD, Hvas AM. Patients Undergoing Oesophageal Cancer Surgery Do Not Have Impaired Haemostasis. Clin Appl Thromb Hemost. 2025 Jan-Dec;31:10760296251327587. doi: 10.1177/10760296251327587. Epub 2025 Mar 17. PMID 40095681
- DERIVEDGyldenholm T, Madsen N, Katballe N, Kjaer DW, Christensen TD, Hvas AM. Thromboprophylaxis in oesophageal cancer patients-a study protocol for a randomised, controlled trial (TOP-RCT). Trials. 2024 Sep 6;25(1):591. doi: 10.1186/s13063-024-08408-y. PMID 39242497