Study of Low Molecular Weight Heparins (DANHEP)

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

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 Overview

• Status: Recruiting
• Conditions: Venous Thromboembolism; Treatment; Prophylaxis; Anticoagulant
• Intervention / Treatment: Drug: Tinzaparin profiled syringe; Drug: Dalteparin Prefilled Syringe

• Study Type: Interventional
• Enrollment (Estimated): 65000
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Kasper Iversen, Professor, MD; Phone Number: + 45 28712753; Email: Kasper.Karmark.Iversen@regionh.dk
• Study Contact Backup: Name: Lars Køber, Professor, MD; Phone Number: + 45 35458525; Email: lars.koeber01@regionh.dk

Study Locations

• Denmark
  • Copenhagen, Denmark
    • Recruiting
    • Rigshospitalet
    • Contact: Lars Køber, Professor, MD; Email: Lars.Koeber.01@regionh.dk
  • Copenhagen, Denmark
    • Recruiting
    • Amager-Hvidovre Hospital
    • Contact: Henriette Svarre, Professor, MD; Email: Henriette.Svarre.Nielsen@regionh.dk
  • Copenhagen, Denmark
    • Recruiting
    • Frederiksberg and Bispebjerg Hospital
    • Contact: Søren Overgaard, Professor, MD
  • Herlev, Denmark, 2730
    • Recruiting
    • Herlev and Gentofte Hospital
    • Contact: Kasper K Iversen, MD, DMsc; Email: Kasper.Karmark.Iversen@regionh.dk
  • Hillerød, Denmark
    • Recruiting
    • Nordsjællands Hospital
    • Contact: Morten Bestle, Professor, MD; Email: Morten.Bestle@regionh.dk
  • Nykøbing Falster, Denmark
    • Recruiting
    • Nykøbing Falster Hospital
    • Contact: Jacob Fyhring Mortensen, MD
    • Contact: Jmot@regionsjaelland.dk
  • Næstved, Denmark
    • Recruiting
    • Næstved, Ringsted, Slagelse Hospital
    • Contact: Henrik Stig Jørgensen, MD; Email: henjor@regionsjaelland.dk
  • Roskilde, Denmark
    • Recruiting
    • Roskilde, Køge Hospital
    • Contact: Lasse Bremholm; Email: labha@regionsjaelland.dk
  • Rønne, Denmark
    • Recruiting
    • Bornholm Hospital
    • Contact: Diana Kaiser; Email: diana.utech.kaiser@regionh.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dalteparin	Drug: 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.
Active Comparator: Tinzaparin	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.

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pregnancy loss	Risk of pregnancy loss during treatment with either of the two drugs studied	9 months
Stillbirth	Risk of stillbirth during treatment with either of the two drugs studied	9 months
Antepartum bleeding	Risk of antepartum bleeding during treatment with either of the two drugs studied	9 months
Postpartum bleeding	Risk of postpartum bleeding during treatment with either of the two drugs studied	up to 365 days
Placental complications	Risk of placental complications (Abruptio placenta, placenta prevue) during treatment with either of the two drugs studied	9 months
Preeclampsia	Risk of preeclampsia and eclampsia during treatment with either of the two drugs studied	9 months

Collaborators and Investigators

• Sponsor: Herlev Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2023
• Primary Completion (Estimated): March 23, 2025
• Study Completion (Estimated): March 23, 2025

Study Registration Dates

• First Submitted: March 27, 2023
• First Submitted That Met QC Criteria: August 29, 2023
• First Posted (Actual): August 31, 2023

Study Record Updates

• Last Update Posted (Actual): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Embolism and Thrombosis; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
• Other Study ID Numbers: DANHEP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No