Study of Low Molecular Weight Heparins

Venous Thromboembolism Clinical Trial

— DANHEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020560
• Other study ID #: DANHEP
• Status: Recruiting
• Phase: Phase 4
• Start date: March 23, 2023
• Est. completion date: March 23, 2025

Study information

• Verified date: August 2023
• Source: Herlev Hospital
• Contact: Kasper Iversen, Professor, MD
• Phone: + 45 28712753
• Email: Kasper.Karmark.Iversen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65000
• Est. completion date: March 23, 2025
• Est. primary completion date: March 23, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant
• Prophylaxis
• Thromboembolism
• Treatment
• Venous Thromboembolism

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Amager-Hvidovre Hospital	Copenhagen
Denmark	Frederiksberg and Bispebjerg Hospital	Copenhagen
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev and Gentofte Hospital	Herlev
Denmark	Nordsjællands Hospital	Hillerød
Denmark	Næstved, Ringsted, Slagelse Hospital	Næstved
Denmark	Nykøbing Falster Hospital	Nykøbing Falster
Denmark	Bornholm Hospital	Rønne
Denmark	Roskilde, Køge Hospital	Roskilde

Sponsors (1)

Lead Sponsor	Collaborator
Herlev Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pregnancy loss	Risk of pregnancy loss during treatment with either of the two drugs studied	9 months
Other	Stillbirth	Risk of stillbirth during treatment with either of the two drugs studied	9 months
Other	Antepartum bleeding	Risk of antepartum bleeding during treatment with either of the two drugs studied	9 months
Other	Postpartum bleeding	Risk of postpartum bleeding during treatment with either of the two drugs studied	up to 365 days
Other	Placental complications	Risk of placental complications (Abruptio placenta, placenta prevue) during treatment with either of the two drugs studied	9 months
Other	Preeclampsia	Risk of preeclampsia and eclampsia during treatment with either of the two drugs studied	9 months
Primary	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	30-day all-cause mortality	Risk of all-cause mortality within 30 days of administering one of the studied drugs	30 days
Secondary	365-day all-cause mortality	Risk of all-cause mortality within 365 days of administering one of the studied drugs	365 days
Secondary	Blood transfusion during admission	Blood transfusion defined from use of blood products	90 days
Secondary	90 day risk of pulmonary embolism	Risk of pulmonary embolism within 90 days of administering one of the drugs studied	90 days
Secondary	90 day risk of deep venous thrombosis	Risk of pulmonary embolism within 90 days of administering one of the drugs studied	90 days
Secondary	Heparin induced thrombocytopenia	Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies	90 days
Secondary	Liver failure	Risk of liver failure defined by ALAT 3X upper limit of normal	90 days
Secondary	Length of hospital admission	Length of hospital admission	Admission time (up to 1 year from inclusion measured in days)
Secondary	Days alive out of hospital	Days alive out of hospital	Time out of hospital (up to 1 year from inclusion measured in days)