NCT05067153

Thromboprophylaxis in Oesophageal Cancer Patients

Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

Hypotheses 1. The intervention group of oesophageal cancer patients, who receive prolonged thromboprophylaxis with Fragmin® has a lower VTE risk, expressed by a lower prothrombin fragment F1+2, 30 days after surgery than the control group, who receive Fragmin® for 10 days. 2. The intervention group does not demonstrate an increased bleeding tendency compared with the control group. 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): * WP1: Randomization of 100 oesophageal cancer patients undergoing intended curative surgery to either a 10 or 30-day prophylactic LMWH-regime. * WP2: Investigation of the coagulation in the WP1 population. The aim is to substantially improve understanding of the coagulation pathophysiology and the mechanisms behind the increased thromboembolic risk in oesophageal cancer patients. * WP3: The lectin pathway complement proteins are suspected to play a role in the increased risk of thrombosis in cancer. We aim to examine this further by measuring complement protein levels in the WP1 population and investigate if there is a correlation between complement levels and changes in the coagulation.

Conditions

• Esophageal Neoplasms
• Thrombosis
• Thromboembolism

Interventions

Type	Name	Description
DRUG	Fragmin 5000 UNT in 0.2 ML Prefilled Syringe	30 days postoperative prophylactic treatment.

Timeline

• Start date: 2021-05-01
• Primary completion: 2023-05-01
• Completion: 2024-05-01
• First posted: 2021-10-05
• Last updated: 2021-10-05

Locations

1 site across 1 country: Denmark