TOP-RCT: Thromboprophylaxis in Oesophageal Cancer Patients

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT05067153

Collaborator

Aarhus University Hospital (Other)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Neoplasms Thrombosis Thromboembolism	Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe	Phase 4

Detailed Description

Hypotheses

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.
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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, controlled trial with one intervention group and one control group.Randomized, controlled trial with one intervention group and one control group.

Masking:

None (Open Label)

Masking Description:

No masking due to ethical considerations. Primary outcome is biochemical.

Primary Purpose:

Prevention

Official Title:

Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial

Actual Study Start Date :

May 1, 2021

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily.	Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe 30 days postoperative prophylactic treatment. Other Names: Low Molecular Weight Heparin
Active Comparator: Control Control group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily.	Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe 30 days postoperative prophylactic treatment. Other Names: Low Molecular Weight Heparin

Arm

Intervention/Treatment

Experimental: Intervention

Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily.

Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe

30 days postoperative prophylactic treatment.

Other Names:

Low Molecular Weight Heparin

Active Comparator: Control

Control group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily.

Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe

30 days postoperative prophylactic treatment.

Other Names:

Low Molecular Weight Heparin

Outcome Measures

Primary Outcome Measures

Prothrombin fragment F1+2 [30 days after surgery.]
Difference in prothrombin fragment F1+2 between the intervention and the control group.

Secondary Outcome Measures

Bleeding [30 days after surgery.]
Incidence of bleeding
Venous thromboembolic events [30 days and one year after surgery]
Incidence of venous thromboembolic events
Mortality [30 days and one year after surgery]
Mortality

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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®).