Incidence of Venous Thromboembolism in Patients Undergoing Major Esophageal Resection

Completed

Conditions studied: Venous Thromboembolism, Thoracic Surgery, Esophageal Cancer

In brief

The purpose of this study is to determine the incidence of post-operative venous thromboembolism (VTE) in patients undergoing major esophageal resection for malignancy.

Key facts

Study ID

NCT03115541

Run by

McMaster University

People needed

187

Starts

2017-07-10

Expected to finish

2020-09-01

Last updated by the study team

2021-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients must be at least 18 years of age.
• Patients may be of either gender.
• Patients must be diagnosed with resectable esophageal cancer.
• Patients must be undergoing an esophagectomy as either the first-line treatment or after completion of neoadjuvant therapies.
• Patients must receive VTE prophylaxis as per local institutional guidelines
• Patients must be competent to understand and sign consent documents.

You may not qualify if…

• All patients with known allergic or anaphylactic reaction to contrast dye, heparin, or low molecular weight heparin (LMWH).
• Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions.
• Patients must not have known renal impairment, defined as creatinine clearance value of less than 55ml/min/m2 as calculated by the Cockcroft-Gault method.
• Patients with a history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites.
• Patients with known hepatic insufficiency, defined as international normalized ratio (INR) >1.5.
• Patients must not be pregnant or planning to become pregnant.
• Patients must not have been diagnosed or treated for VTE in the past 3 months prior to surgery.
• Patients must not have a present or previous increased risk of haemorrhage.
• Patients must not have known, objectively confirmed bleeding and clotting disorders such as thrombophilia, von Willebrand's disease, hemophilia or otherwise active bleeding.
• Patients must not have a history of previous heparin-induced thrombocytopenia (HIT).
• Platelet count must be above 75,000, but transient, recovered thrombocytopenia associated with chemotherapy will not be a basis for exclusion.
• Patients must not have previously inserted inferior vena cava (IVC) filter.

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Manitoba — Winnipeg, Manitoba, Canada
• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Beijing Chao-yang Hospital, Capital Medical University — Beijing, China

Full record on ClinicalTrials.gov

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