AnticoagulantPhase 4DANHEPNCT06020560
Study of Low Molecular Weight Heparins
A Phase 4 study testing Dalteparin Prefilled Syringe and Tinzaparin profiled syringe in people with Anticoagulant and Venous Thromboembolism, run by Herlev Hospital at 9 sites in Denmark.
Trial summary
DANHEP is a cluster randomized study of two different low molecular weight heparins. Parenteral anticoagulants are used in a variety of settings, including treatment and prevention of venous thromboembolism in cancer patients, medical patients, and surgical patients, along with the use as adjuvant therapy for coronary… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant, Venous Thromboembolism, Prophylaxis
- What is being tested?
- Dalteparin Prefilled Syringe and Tinzaparin profiled syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65,000 participants
- Where
- 9 sitesDenmark
- Study dates
- 23 Mar 2023to 23 Mar 2025
- 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
- All patients with indication for low molecular weight heparin
Who cannot join
- Patients under the age of 18
- Patients who are incapable of understanding the written material received
- Patients who after being informed in writing chooses not to participate
- Patients with contraindications for low molecular weight heparins as described in the SmPC
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Denmark9 sites, 9 recruiting
- Recruiting
Amager-Hvidovre Hospital
Copenhagen
Henriette Svarre, Professor, MD, Henriette.Svarre.Nielsen@regionh.dk
- Recruiting
Frederiksberg and Bispebjerg Hospital
Copenhagen
Søren Overgaard, Professor, MD
- Recruiting
Rigshospitalet
Copenhagen
Lars Køber, Professor, MD, Lars.Koeber.01@regionh.dk
- Recruiting
Herlev and Gentofte Hospital
Herlev, 2730
Kasper K Iversen, MD, DMsc, Kasper.Karmark.Iversen@regionh.dk
- Recruiting
Nordsjællands Hospital
Hillerød
Morten Bestle, Professor, MD, Morten.Bestle@regionh.dk
- Recruiting
Næstved, Ringsted, Slagelse Hospital
Næstved
Henrik Stig Jørgensen, MD, henjor@regionsjaelland.dk
- Recruiting
Nykøbing Falster Hospital
Nykøbing Falster
Jacob Fyhring Mortensen, MD
Jmot@regionsjaelland.dk
- Recruiting
Bornholm Hospital
Rønne
Diana Kaiser, diana.utech.kaiser@regionh.dk
- Recruiting
Roskilde, Køge Hospital
Roskilde
Lasse Bremholm, labha@regionsjaelland.dk
About this study
Official title: Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC
DANHEP is a cluster randomized study of two different low molecular weight heparins. Parenteral anticoagulants are used in a variety of settings, including treatment and prevention of venous thromboembolism in cancer patients, medical patients, and surgical patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently used parenteral anticoagulants in Denmark, include the two different low molecular weight heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is a lack of evidence regarding whether these drugs are in fact comparable. The aim of this study is therefore to investigate the comparative safety and efficacy of the two different low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in patients with an indication for low molecular weight heparins.
- Conditions
- Anticoagulant, Venous Thromboembolism, Prophylaxis, Treatment
- Being tested
- Dalteparin Prefilled Syringe, Tinzaparin profiled syringe
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalteparin Prefilled SyringeDrug
Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
Tinzaparin profiled syringeDrug
Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Dalteparin | Active comparator | Not described Receives: Drug: Tinzaparin profiled syringe |
| Tinzaparin | Active comparator | Not described Receives: Drug: Dalteparin Prefilled Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day all-cause mortality and bleeding requiring blood transfusion
To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring blood transfusion during admission or death within 30 days in patients with indication for low molecular weight heparins.
Measured: 30 days
Secondary outcomes (9)
30-day all-cause mortality
Risk of all-cause mortality within 30 days of administering one of the studied drugs
Measured: 30 days
365-day all-cause mortality
Risk of all-cause mortality within 365 days of administering one of the studied drugs
Measured: 365 days
Blood transfusion during admission
Blood transfusion defined from use of blood products
Measured: 90 days
90 day risk of pulmonary embolism
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Measured: 90 days
90 day risk of deep venous thrombosis
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Measured: 90 days
Heparin induced thrombocytopenia
Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies
Measured: 90 days
Liver failure
Risk of liver failure defined by ALAT 3X upper limit of normal
Measured: 90 days
Length of hospital admission
Length of hospital admission
Measured: Admission time (up to 1 year from inclusion measured in days)
Days alive out of hospital
Days alive out of hospital
Measured: Time out of hospital (up to 1 year from inclusion measured in days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start23 Mar 2023
- Primary completion23 Mar 2025 (estimated)
- Study completion23 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulantStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kasper Iversen, Herlev Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06020560
- Sponsor's protocol ID
- DANHEP
- Acronym
- DANHEP
- Status last verified
- Aug 2023
- First submitted
- 27 Mar 2023
- Last updated
- 31 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC
- ClinicalTrials.gov ID
- NCT06020560
- Acronym / sponsor ID
- DANHEP / DANHEP
- Conditions
- Anticoagulant, Venous Thromboembolism, Prophylaxis, Treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 65,000 participants (estimated)
- Lead sponsor
- Herlev HospitalUniversity, hospital or other
- Study start
- 23 Mar 2023 (actual)
- Primary completion
- 23 Mar 2025 (estimated)
- Study completion
- 23 Mar 2025 (estimated)
- First posted
- 31 Aug 2023 (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.
DANHEP is a cluster randomized study of two different low molecular weight heparins. Parenteral anticoagulants are used in a variety of settings, including treatment and prevention of venous thromboembolism in cancer patients, medical patients, and surgical patients, along with the use as adjuvant therapy for coronary syndromes. The most frequently used parenteral anticoagulants in Denmark, include the two different low molecular weight heparins; dalteparin and tinzaparin. The two drugs are considered equally efficient and safe regarding treatment and prevention of thrombosis and risk of bleeding. Importantly, there is a lack of evidence regarding whether these drugs are in fact comparable. The aim of this study is therefore to investigate the comparative safety and efficacy of the two different low molecular weight heparins (dalteparin and tinzaparin using cluster randomization in patients with an indication for low molecular weight heparins.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dalteparin | Active comparator | Drug: Tinzaparin profiled syringe |
| Tinzaparin | Active comparator | Drug: Dalteparin Prefilled Syringe |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with indication for low molecular weight heparin
Key exclusion criteria (4 listed)
- Patients under the age of 18
- Patients who are incapable of understanding the written material received
- Patients who after being informed in writing chooses not to participate
- Patients with contraindications for low molecular weight heparins as described in the SmPC
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 |
|---|---|---|
| Dalteparin Prefilled SyringePatients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour. | Drug | Tinzaparin |
| Tinzaparin profiled syringePatients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour. | Drug | Dalteparin |
Primary outcome
30-day all-cause mortality and bleeding requiring blood transfusion
Time frame: 30 days
To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring blood transfusion during admission or death within 30 days in patients with indication for low molecular weight heparins.
9 secondary outcomes
30-day all-cause mortality
Time frame: 30 days
365-day all-cause mortality
Time frame: 365 days
Blood transfusion during admission
Time frame: 90 days
90 day risk of pulmonary embolism
Time frame: 90 days
90 day risk of deep venous thrombosis
Time frame: 90 days
Heparin induced thrombocytopenia
Time frame: 90 days
Liver failure
Time frame: 90 days
Length of hospital admission
Time frame: Admission time (up to 1 year from inclusion measured in days)
Days alive out of hospital
Time frame: Time out of hospital (up to 1 year from inclusion measured in days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dalteparin Prefilled Syringe and Tinzaparin profiled syringe in people with Anticoagulant and Venous Thromboembolism, run by Herlev Hospital at 9 sites 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 1 inclusion and 4 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 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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 Kasper Iversen, Professor, MD (+ 45 28712753, Kasper.Karmark.Iversen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day all-cause mortality and bleeding requiring blood transfusion (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2023.