Prevention of blood clots after surgery in patients with oesophageal cancer

Thromboprophylaxis in Oesophageal Cancer Patients – A Randomized, Controlled Trial - Thromboprophylaxis in Oespohageal Cancer Patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-001335-24-DK

Enrollment

100

Registered

2021-05-11

Start date

2021-08-06

Completion date

Unknown

Last updated

2024-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thromboembolism in oesophageal cancer MedDRA version: 20.0 Level: HLT Classification code 10030176 Term: Oesophageal neoplasms malignant System Organ Class: 100000004856

Interventions

Trade Name: Fragmin Product Name: Fragmin Pharmaceutical Form: Injection INN or Proposed INN: Fragmin Other descriptive name: DALTEPARIN SODIUM Concentration unit: IU international unit(s) Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

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

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®).

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

Denmark

Contacts

Public ContactDepartment of Clinical Biochemistry

Aarhus University Hospital

biokemi@auh.rm.dk004578455252

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026