Safety and Efficacy of Thromboprophylaxis in Oesophageal Cancer Patients

Study design

Randomized controlled trial.

About the project

Patients who undergo surgery for cancer in the oesophagus have an increased risk of thrombosis after surgery. They therefore receive thromboprophylactic treatment for 10 days. However, recent research indicates that a prolonged, 30-day treatment may benefit the patients without unduly increasing the bleeding risk.

We aim to include 100 patients from Department of Cardiothoracic and Vascular Surgery at Aarhus University Hospital. The patients are randomized to receive either the standard or the prolonged treatment. Blood samples are taken before and during the operation, as well as one and 30 days postoperatively. The samples are analysed with a comprehensive array of coagulation tests in to estimate the risk of thrombosis and bleeding in this patient group. Furthermore, the patients are scanned with ultrasound of the lower extremities before and 30 days after surgery to diagnose potential deep venous thrombosis.

The perspective of the study is to lower the risk of potentially fatal thrombosis after surgery for oesophageal cancer, aiming to increase the survival for this patient group. Furthermore, results from the study will increase the understanding of coagulation activity during and after surgery in this patient group.

Objective(s)

The purpose of the study is to examine if a prolonged, 30-day thromboprophylactic treatment with Fragmin® reduces the risk of thrombosis after surgery for oesophageal cancer, compared to the standard, 10-day treatment.

Collaboration

The project is a collaboration between Department of Cardiothoracic and Vascular Surgery, Department of Clinical Biochemistry and Department of Surgery, Aarhus University Hospital. We collaborate internationally with Medizinische Universität in Innsbruck, Austria and nationally with Department of Biomedicine, Aarhus University with investigations of fibrin network formation and lectin pathway proteins, respectively.

Project group

  • Tua Gyldenholm, MD, PhD Student
  • Thomas Decker Christensen, MD, PhD, DMSc, Clinical Professor and Chair, Consultant
  • Niels Katballe, MD, PhD, Consultant
  • Daniel W Kjær, MD, PhD, Clinical Associate Professor, Consultant
  • Anne-Mette Hvas, MD, PhD, Clinical Professor, Consultant

Funding

The project has received funding from Department of Cardiothoracic and Vascular Surgery and Department of Clinical Biochemistry, Aarhus University Hospital as well as Aarhus University.

Status

Ongoing. Currently enrolling patients.

Project period

Start: 1 May 2021
End: 1 May 2024

Contact

Project leader

Principal investigator & main supervisor

Supervisors

Daniel Willy Kjær

Clinical Associate Professor

Niels Katballe

Clinical Associate Professor

Thomas Decker Christensen

Clinical Professor and Chair, Senior Consultant, MD, DMSc, PhD

Participation requirements

Patients with oesophageal cancer scheduled for surgery at Aarhus University Hospital are asked if they wish to participate.