NCT06020560

Study of Low Molecular Weight Heparins

Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 65,000 (estimated)
• Sponsor: Herlev Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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

Interventions

Type	Name	Description
DRUG	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.
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.

Timeline

• Start date: 2023-03-23
• Primary completion: 2025-03-23
• Completion: 2025-03-23
• First posted: 2023-08-31
• Last updated: 2023-08-31

Locations

9 sites across 1 country: Denmark