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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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.
Hypotheses
Primary endpoint The primary endpoint is the difference in prothrombin fragment F1+2 30 days after surgery between the intervention and the control group.
Secondary and safety endpoints The secondary endpoints are incidence of bleeding, VTE and mortality 30 days and one year after surgery.
Study design
The study is comprised of three specific objectives, presented in three work packages (WP):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily. |
|
| Control | Active Comparator | Control group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fragmin 5000 UNT in 0.2 ML Prefilled Syringe | Drug | 30 days postoperative prophylactic treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prothrombin fragment F1+2 | Difference in prothrombin fragment F1+2 between the intervention and the control group. | 30 days after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Bleeding | Incidence of bleeding | 30 days after surgery. |
| Venous thromboembolic events | Incidence of venous thromboembolic events | 30 days and one year after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anne-Mette Hvas, MD | Contact | 004578455252 | annehvas@rm.dk | |
| Tua Gyldenholm, MD | Contact | 004525136781 | tuagyl@clin.au.dk |
| Name | Affiliation | Role |
|---|---|---|
| Anne-Mette Hvas, MD | University of Aarhus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital | Recruiting | Aarhus N | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40095681 | Derived | Gyldenholm 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. | |
| 39242497 | Derived | Gyldenholm 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. |
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| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D013927 | Thrombosis |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| ID | Term |
|---|---|
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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Randomized, controlled trial with one intervention group and one control group.
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No masking due to ethical considerations. Primary outcome is biochemical.
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| Mortality | Mortality | 30 days and one year after surgery |
| D006258 |
| Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |