Esophageal NeoplasmsPhase 4TOP-RCTNCT05067153
Thromboprophylaxis in Oesophageal Cancer Patients
A Phase 4 study testing Fragmin 5000 UNT in 0.2 ML Prefilled Syringe in people with Esophageal Neoplasms and Thrombosis, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Neoplasms, Thrombosis, Thromboembolism
- What is being tested?
- Fragmin 5000 UNT in 0.2 ML Prefilled Syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2021to 1 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cancer located in oesophagus and/or cardia.
- Candidate for intended curative surgery.
- Age > 18 years.
Who cannot join
- 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®).
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Thrombosis and Haemostasis Research Unit, Department for Clinical Biochemistry, Aarhus University Hospital
Aarhus N, 8000
Anne-Mette Hvas, MD, Ph.D., +45 2334 8252, annehvas@rm.dk
Anne-Mette Hvas, MD, Ph.D.
About this study
Official title: Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Esophageal Neoplasms, Thrombosis, Thromboembolism
- Being tested
- Fragmin 5000 UNT in 0.2 ML Prefilled Syringe
- Keywords
- Esophageal cancer
- Medical subject headings
- Esophageal Neoplasms, Thrombosis, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fragmin 5000 UNT in 0.2 ML Prefilled SyringeDrug
Also called Low Molecular Weight Heparin
30 days postoperative prophylactic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Intervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily. Receives: 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. Receives: Drug: Fragmin 5000 UNT in 0.2 ML Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prothrombin fragment F1+2
Difference in prothrombin fragment F1+2 between the intervention and the control group.
Measured: 30 days after surgery.
Secondary outcomes (3)
Bleeding
Incidence of bleeding
Measured: 30 days after surgery.
Venous thromboembolic events
Incidence of venous thromboembolic events
Measured: 30 days and one year after surgery
Mortality
Mortality
Measured: 30 days and one year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start1 May 2021
- Primary completion1 May 2023 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Esophageal NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled trial with one intervention group and one control group.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Sponsor
- Investigators
- Anne-Mette Hvas, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05067153
- Sponsor's protocol ID
- 2021-001335-24
- Acronym
- TOP-RCT
- Status last verified
- Sep 2021
- First submitted
- 23 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40095681Gyldenholm 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.
PubMed 39242497
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboprophylaxis in Oesophageal Cancer Patients - A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT05067153
- Acronym / sponsor ID
- TOP-RCT / 2021-001335-24
- Conditions
- Esophageal Neoplasms, Thrombosis, Thromboembolism
- Keywords
- Esophageal cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled trial with one intervention group and one control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Fragmin 5000 UNT in 0.2 ML Prefilled SyringeIntervention group (n=50, anticipated) receives 30 days postoperative treatment with 5000 IE LMWH daily. |
| Control | Active comparator | Drug: Fragmin 5000 UNT in 0.2 ML Prefilled SyringeControl group (n=50, anticipated) receives standard 10 days postoperative treatment with 5000 IE LMWH daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Cancer located in oesophagus and/or cardia.
- Candidate for intended curative surgery.
- Age > 18 years.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fragmin 5000 UNT in 0.2 ML Prefilled SyringeAlso: Low Molecular Weight Heparin30 days postoperative prophylactic treatment. | Drug | Control, Intervention |
Primary outcome
Prothrombin fragment F1+2
Time frame: 30 days after surgery.
Difference in prothrombin fragment F1+2 between the intervention and the control group.
3 secondary outcomes
Bleeding
Time frame: 30 days after surgery.
Venous thromboembolic events
Time frame: 30 days and one year after surgery
Mortality
Time frame: 30 days and one year after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Derived from this study: PubMed 40095681Gyldenholm 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.
- Derived from this study: PubMed 39242497Gyldenholm 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Mette Hvas, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fragmin 5000 UNT in 0.2 ML Prefilled Syringe in people with Esophageal Neoplasms and Thrombosis, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Mette Hvas, MD (004578455252, annehvas@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prothrombin fragment F1+2 (time frame: 30 days after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05067153, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021.