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Study of Low Molecular Weight Heparins

NCT ID: NCT06020560

Last Updated: 2023-08-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

65000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2025-03-23

Brief Summary

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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.

Detailed Description

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Conditions

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Anticoagulant Venous Thromboembolism Prophylaxis Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dalteparin

Group Type ACTIVE_COMPARATOR

Tinzaparin profiled syringe

Intervention Type DRUG

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

Group Type ACTIVE_COMPARATOR

Dalteparin Prefilled Syringe

Intervention Type DRUG

Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.

Interventions

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Dalteparin Prefilled Syringe

Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.

Intervention Type DRUG

Tinzaparin profiled syringe

Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients with indication for low molecular weight heparin

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kasper Iversen

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amager-Hvidovre Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Frederiksberg and Bispebjerg Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Herlev and Gentofte Hospital

Herlev, , Denmark

Site Status RECRUITING

Nordsjællands Hospital

Hillerød, , Denmark

Site Status RECRUITING

Nykøbing Falster Hospital

Nykøbing Falster, , Denmark

Site Status RECRUITING

Næstved, Ringsted, Slagelse Hospital

Næstved, , Denmark

Site Status RECRUITING

Roskilde, Køge Hospital

Roskilde, , Denmark

Site Status RECRUITING

Bornholm Hospital

Rønne, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Kasper Iversen, Professor, MD

Role: CONTACT

Phone: + 45 28712753

Email: [email protected]

Lars Køber, Professor, MD

Role: CONTACT

Phone: + 45 35458525

Email: [email protected]

Facility Contacts

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Henriette Svarre, Professor, MD

Role: primary

Søren Overgaard, Professor, MD

Role: primary

Lars Køber, Professor, MD

Role: primary

Kasper K Iversen, MD, DMsc

Role: primary

Morten Bestle, Professor, MD

Role: primary

Jacob Fyhring Mortensen, MD

Role: primary

[email protected]

Role: backup

Henrik Stig Jørgensen, MD

Role: primary

Lasse Bremholm

Role: primary

Diana Kaiser

Role: primary

Other Identifiers

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DANHEP

Identifier Type: -

Identifier Source: org_study_id