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Study of Low Molecular Weight Heparins (DANHEP)

H

Herlev Hospital

Status and phase

Enrolling
Phase 4

Conditions

Venous Thromboembolism
Treatment
Prophylaxis
Anticoagulant

Treatments

Drug: Dalteparin Prefilled Syringe
Drug: Tinzaparin profiled syringe

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

65,000 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

65,000 participants in 2 patient groups

Dalteparin
Active Comparator group
Treatment:
Drug: Tinzaparin profiled syringe
Tinzaparin
Active Comparator group
Treatment:
Drug: Dalteparin Prefilled Syringe

Trial contacts and locations

9

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Central trial contact

Lars Køber, Professor, MD; Kasper Iversen, Professor, MD

Data sourced from clinicaltrials.gov

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