Comparing two types of low molecular weight heparins for treating blood clots
Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC
This study tests whether two blood-thinning medications, dalteparin and tinzaparin, work differently for people with blood clots.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 65000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Herlev Hospital Academic / other |
| Locations | 9 sites (Copenhagen and 8 other locations) |
| Trial ID | NCT06020560 on ClinicalTrials.gov |
What this trial studies
This study investigates the safety and efficacy of two low molecular weight heparins, dalteparin and tinzaparin, in patients requiring anticoagulation for venous thromboembolism. It employs a cluster randomized design to compare these two medications, which are commonly used in Denmark. The goal is to determine if there are significant differences in outcomes between the two drugs, which are generally considered equally effective. The study aims to provide clearer evidence on their comparability in clinical settings.
Who should consider this trial
Good fit: Ideal candidates include patients with a medical indication for low molecular weight heparin therapy.
Not a fit: Patients under 18 years old or those with contraindications for low molecular weight heparins will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide definitive evidence to guide clinicians in choosing the most effective anticoagulant for patients at risk of blood clots.
How similar studies have performed: While there have been studies on low molecular weight heparins, this specific comparative approach using cluster randomization is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Copenhagen and 8 other locations
- Amager-Hvidovre Hospital — Copenhagen, Denmark (Recruiting)
- Frederiksberg and Bispebjerg Hospital — Copenhagen, Denmark (Recruiting)
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
- Herlev and Gentofte Hospital — Herlev, Denmark (Recruiting)
- Nordsjællands Hospital — Hillerød, Denmark (Recruiting)
- Nykøbing Falster Hospital — Nykøbing Falster, Denmark (Recruiting)
- Næstved, Ringsted, Slagelse Hospital — Næstved, Denmark (Recruiting)
- Roskilde, Køge Hospital — Roskilde, Denmark (Recruiting)
- Bornholm Hospital — Rønne, Denmark (Recruiting)
Study contacts
- Study coordinator: Kasper Iversen, Professor, MD
- Email: Kasper.Karmark.Iversen@regionh.dk
- Phone: + 45 28712753
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.