Study of Low Molecular Weight Heparins
- Conditions
- ProphylaxisVenous ThromboembolismAnticoagulantTreatment
- Interventions
- Registration Number
- NCT06020560
- Lead Sponsor
- Herlev Hospital
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65000
- All patients with indication for low molecular weight heparin
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tinzaparin Dalteparin Prefilled Syringe - Dalteparin Tinzaparin profiled syringe -
- Primary Outcome Measures
Name Time Method 30-day all-cause mortality and bleeding requiring blood transfusion 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.
- Secondary Outcome Measures
Name Time Method Blood transfusion during admission 90 days Blood transfusion defined from use of blood products
90 day risk of pulmonary embolism 90 days Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Length of hospital admission Admission time (up to 1 year from inclusion measured in days) Length of hospital admission
30-day all-cause mortality 30 days Risk of all-cause mortality within 30 days of administering one of the studied drugs
365-day all-cause mortality 365 days Risk of all-cause mortality within 365 days of administering one of the studied drugs
Heparin induced thrombocytopenia 90 days Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies
90 day risk of deep venous thrombosis 90 days Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Liver failure 90 days Risk of liver failure defined by ALAT 3X upper limit of normal
Days alive out of hospital Time out of hospital (up to 1 year from inclusion measured in days) Days alive out of hospital
Trial Locations
- Locations (9)
Herlev and Gentofte Hospital
🇩🇰Herlev, Denmark
Nykøbing Falster Hospital
🇩🇰Nykøbing Falster, Denmark
Rigshospitalet
🇩🇰Copenhagen, Denmark
Amager-Hvidovre Hospital
🇩🇰Copenhagen, Denmark
Frederiksberg and Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Nordsjællands Hospital
🇩🇰Hillerød, Denmark
Næstved, Ringsted, Slagelse Hospital
🇩🇰Næstved, Denmark
Roskilde, Køge Hospital
🇩🇰Roskilde, Denmark
Bornholm Hospital
🇩🇰Rønne, Denmark