NCT05067153|UnknownPhase 4DMC
Thromboprophylaxis in Oesophageal Cancer Patients
TOP-RCT
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TOP-RCT
Sponsor study identifier
interventional
100
1 country
1
Study Start
May 1, 2021
Actual (reported)Primary Completion
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 1, 2021
Actual (reported)September 23, 2021
Actual (reported)October 5, 2021
Actual (reported)May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Prothrombin fragment F1+2
Difference in prothrombin fragment F1+2 between the intervention and the control group.
30 days after surgery.
Bleeding
30 days after surgery.
Venous thromboembolic events
30 days and one year after surgery
Mortality
30 days and one year after surgery
Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily.
Control group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily.
30 days postoperative prophylactic treatment.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital
Aarhus N, 8000, Denmark
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.
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.
Anne-Mette Hvas, MD
University of Aarhus
First Submitted
September 23, 2021
First Posted
October 5, 2021
Study Start
May 1, 2021
Actual (reported)Primary Completion
Contact the study team to confirm eligibility.
May 1, 2023
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 1, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
October 5, 2021
Record last verified: 2021-09
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Source: ClinicalTrials.gov.
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