Thromboprophylaxis in Oesophageal Cancer Patients (TOP-RCT)

University of Aarhus

Status and phase: Unknown; Phase 4

Conditions: Thromboembolism; Thrombosis; Esophageal Neoplasms

Treatments: Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT05067153

2021-001335-24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Intervention

Experimental group

Description:

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

Treatment:

Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe

Control

Active Comparator group

Description:

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

Treatment:

Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe