Thromboprophylaxis in Oesophageal Cancer Patients

Thrombosis Clinical Trial

— TOP-RCT  

Official title:

Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05067153
• Other study ID #: 2021-001335-24
• Status: Recruiting
• Phase: Phase 4
• Start date: May 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: September 2021
• Source: University of Aarhus
• Contact: Anne-Mette Hvas, MD
• Phone: 004578455252
• Email: annehvas[@]rm.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Cancer located in oesophagus and/or cardia.

2. Candidate for intended curative surgery.

3. Age > 18 years.

Exclusion Criteria:

1. Known inherited bleeding disorder.

2. Unable to provide informed consent.

3. Arterial or venous thromboembolic events within the last three months.

4. On-going anticoagulant treatment (Vitamin K antagonists or direct oral anticoagulants).

5. Pregnant or has given birth within the last three months.

6. Known allergy to the trial drug Dalteparin (Fragmin®).

Related Conditions & MeSH terms

• Esophageal Neoplasms
• Thromboembolism
• Thrombosis

Intervention

Drug:
• Fragmin 5000 UNT in 0.2 ML Prefilled Syringe
30 days postoperative prophylactic treatment.

Locations

Country	Name	City	State
Denmark	Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital	Aarhus N

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prothrombin fragment F1+2	Difference in prothrombin fragment F1+2 between the intervention and the control group.	30 days after surgery.
Secondary	Bleeding	Incidence of bleeding	30 days after surgery.
Secondary	Venous thromboembolic events	Incidence of venous thromboembolic events	30 days and one year after surgery
Secondary	Mortality	Mortality	30 days and one year after surgery