NCT05067153

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2021

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

October 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2 years

First QC Date

September 23, 2021

Last Update Submit

September 23, 2021

Conditions

Esophageal NeoplasmsThrombosisThromboembolism

Keywords

Esophageal cancer

Outcome Measures

Primary Outcomes (1)

  • Prothrombin fragment F1+2

    Difference in prothrombin fragment F1+2 between the intervention and the control group.

    30 days after surgery.

Secondary Outcomes (3)

  • Bleeding

    30 days after surgery.

  • Venous thromboembolic events

    30 days and one year after surgery

  • Mortality

    30 days and one year after surgery

Study Arms (2)

Intervention

EXPERIMENTAL

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

Control

ACTIVE COMPARATOR

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

Interventions

Fragmin 5000 UNT in 0.2 ML Prefilled SyringeDRUG

30 days postoperative prophylactic treatment.

Also known as: Low Molecular Weight Heparin
ControlIntervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cancer located in oesophagus and/or cardia.
  • Candidate for intended curative surgery.
  • Age \> 18 years.

You may not qualify if:

  • 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®).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital

Aarhus N, 8000, Denmark

RECRUITING

Related Publications (2)

  • Gyldenholm T, Madsen N, Katballe N, Kjaer DW, Christensen TD, Hvas AM. Patients Undergoing Oesophageal Cancer Surgery Do Not Have Impaired Haemostasis. Clin Appl Thromb Hemost. 2025 Jan-Dec;31:10760296251327587. doi: 10.1177/10760296251327587. Epub 2025 Mar 17.

    PMID: 40095681DERIVED

  • Gyldenholm T, Madsen N, Katballe N, Kjaer DW, Christensen TD, Hvas AM. Thromboprophylaxis in oesophageal cancer patients-a study protocol for a randomised, controlled trial (TOP-RCT). Trials. 2024 Sep 6;25(1):591. doi: 10.1186/s13063-024-08408-y.

    PMID: 39242497DERIVED

MeSH Terms

Conditions

Esophageal NeoplasmsThrombosisThromboembolism

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Anne-Mette Hvas, MD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne-Mette Hvas, MD

CONTACT

004578455252annehvas@rm.dk

Tua Gyldenholm, MD

CONTACT

004525136781tuagyl@clin.au.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking due to ethical considerations. Primary outcome is biochemical.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized, controlled trial with one intervention group and one control group.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2021

First Posted

October 5, 2021

Study Start

May 1, 2021

Primary Completion

May 1, 2023

Study Completion

May 1, 2024

Last Updated

October 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)