Study of Low Molecular Weight Heparins

Study Overview
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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.

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

Conditions
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Anticoagulant, Venous Thromboembolism, Prophylaxis, Treatment

Intervention / Treatment
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* Drug: Dalteparin Prefilled Syringe
* Drug: Tinzaparin profiled syringe


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dalteparin<br> | Drug: Tinzaparin profiled syringe<br>* Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.<br>|
| Active Comparator: Tinzaparin<br> | Drug: Dalteparin Prefilled Syringe<br>* Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-day all-cause mortality | Risk of all-cause mortality within 30 days of administering one of the studied drugs | 30 days | 
| 365-day all-cause mortality | Risk of all-cause mortality within 365 days of administering one of the studied drugs | 365 days | 
| Blood transfusion during admission | Blood transfusion defined from use of blood products | 90 days | 
| 90 day risk of pulmonary embolism | Risk of pulmonary embolism within 90 days of administering one of the drugs studied | 90 days | 
| 90 day risk of deep venous thrombosis | Risk of pulmonary embolism within 90 days of administering one of the drugs studied | 90 days | 
| Heparin induced thrombocytopenia | Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies | 90 days | 
| Liver failure | Risk of liver failure defined by ALAT 3X upper limit of normal | 90 days | 
| Length of hospital admission | Length of hospital admission | Admission time (up to 1 year from inclusion measured in days) | 
| Days alive out of hospital | Days alive out of hospital | Time out of hospital (up to 1 year from inclusion measured in days) |