Thromboprophylaxis in Oesophageal Cancer Patients

  • STATUS
    Recruiting
  • End date
    May 1, 2024
  • participants needed
    100
  • sponsor
    University of Aarhus
Updated on 10 October 2021
cancer
esophagus cancer

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.

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.

Details
Condition Blood Clots, head and neck cancer, thromboembolic event, Esophageal Diseases, Head and Neck Cancer, Thrombosis, Esophageal Disorders, clot, blood clotting, thromboembolic disease, Thromboembolic Events, Thromboembolism, Esophageal Cancer
Treatment Fragmin 5000 UNT in 0.2 ML Prefilled Syringe
Clinical Study IdentifierNCT05067153
SponsorUniversity of Aarhus
Last Modified on10 October 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Cancer located in oesophagus and/or cardia
Candidate for intended curative surgery
Age > 18 years

Exclusion Criteria

Known inherited bleeding disorder
Unable to provide informed consent
Arterial or venous thromboembolic events within the last three months
On-going anticoagulant treatment (Vitamin K antagonists or direct oral anticoagulants)
Pregnant or has given birth within the last three months
Known allergy to the trial drug Dalteparin (Fragmin)
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note