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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
65,000
Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
Amager-Hvidovre Hospital
Copenhagen, Denmark
RECRUITINGFrederiksberg and Bispebjerg Hospital
Copenhagen, Denmark
RECRUITINGRigshospitalet
Copenhagen, Denmark
RECRUITINGHerlev and Gentofte Hospital
Herlev, Denmark
RECRUITINGNordsjællands Hospital
Hillerød, Denmark
RECRUITINGNykøbing Falster Hospital
Nykøbing Falster, Denmark
RECRUITINGNæstved, Ringsted, Slagelse Hospital
Næstved, Denmark
RECRUITINGRoskilde, Køge Hospital
Roskilde, Denmark
RECRUITINGBornholm Hospital
Rønne, Denmark
RECRUITING30-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.
Time frame: 30 days
30-day all-cause mortality
Risk of all-cause mortality within 30 days of administering one of the studied drugs
Time frame: 30 days
365-day all-cause mortality
Risk of all-cause mortality within 365 days of administering one of the studied drugs
Time frame: 365 days
Blood transfusion during admission
Blood transfusion defined from use of blood products
Time frame: 90 days
90 day risk of pulmonary embolism
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Time frame: 90 days
90 day risk of deep venous thrombosis
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Time frame: 90 days
Heparin induced thrombocytopenia
Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies
Time frame: 90 days
Liver failure
Risk of liver failure defined by ALAT 3X upper limit of normal
Time frame: 90 days
Length of hospital admission
Length of hospital admission
Time frame: Admission time (up to 1 year from inclusion measured in days)
Days alive out of hospital
Days alive out of hospital
Time frame: Time out of hospital (up to 1 year from inclusion measured in days)
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