Prevention of blood clots after surgery in patients with oesophageal cancer

Phase 1

Conditions: Thromboembolism in oesophageal cancer
MedDRA version: 20.0Level: HLTClassification code 10030176Term: Oesophageal neoplasms malignantSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2021-001335-24-DK

Lead Sponsor: Aarhus University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 100

Inclusion Criteria

1.Cancer located in the oesophagus and/or cardia
2.Candidate for intended curative surgery.
3.Age > 18 years.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

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®).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of the study is to examine the efficacy and safety of prolonged thromboprophylactic treatment with Fragmin® in oesophageal cancer patients undergoing intended curative surgery. ;Secondary Objective: Not applicable;Primary end point(s): The change in prothrombin fragment F1+2 30 days after surgery between the intervention and the control group.;Timepoint(s) of evaluation of this end point: The primary end point will be evaluated after the collection of all data. No interim analyses will be performed.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary endpoints are incidence of bleeding, VTE and mortality 30 days and one year after surgery.;Timepoint(s) of evaluation of this end point: The secondary end points will be evaluated after the collection of all data. No interim analyses will be performed.