Clinical trial NCT06020560: Study of Low Molecular Weight Heparins
Official title: Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Anticoagulant
Venous Thromboembolism
Prophylaxis
Treatment
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2023-08-31
Enrollment: 65000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 30-day all-cause mortality and bleeding requiring blood transfusion
timeFrame: 30 days
Secondary outcomes:
measure: 30-day all-cause mortality
timeFrame: 30 days
measure: 365-day all-cause mortality
timeFrame: 365 days
measure: Blood transfusion during admission
timeFrame: 90 days
measure: 90 day risk of pulmonary embolism
timeFrame: 90 days
measure: 90 day risk of deep venous thrombosis
timeFrame: 90 days
measure: Heparin induced thrombocytopenia
timeFrame: 90 days
measure: Liver failure
timeFrame: 90 days
measure: Length of hospital admission
timeFrame: Admission time (up to 1 year from inclusion measured in days)
measure: Days alive out of hospital
timeFrame: Time out of hospital (up to 1 year from inclusion measured in days)
Other outcomes:
measure: Pregnancy loss
timeFrame: 9 months
measure: Stillbirth
timeFrame: 9 months
measure: Antepartum bleeding
timeFrame: 9 months
measure: Postpartum bleeding
timeFrame: up to 365 days
measure: Placental complications
timeFrame: 9 months
measure: Preeclampsia
timeFrame: 9 months
Locations:
city: Copenhagen
country: Denmark
facility: Amager-Hvidovre Hospital
city: Copenhagen
country: Denmark
facility: Frederiksberg and Bispebjerg Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Hillerød
country: Denmark
facility: Nordsjællands Hospital
city: Nykøbing Falster
country: Denmark
facility: Nykøbing Falster Hospital
city: Næstved
country: Denmark
facility: Næstved, Ringsted, Slagelse Hospital
city: Roskilde
country: Denmark
facility: Roskilde, Køge Hospital
city: Rønne
country: Denmark
facility: Bornholm Hospital
Study officials:
References: