NCT06020560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65,000

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

9 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2025

Completed
Last Updated

August 31, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

March 27, 2023

Last Update Submit

August 29, 2023

Conditions

AnticoagulantVenous ThromboembolismProphylaxisTreatment

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • 30-day all-cause mortality

    30 days

  • 365-day all-cause mortality

    365 days

  • Blood transfusion during admission

    90 days

  • 90 day risk of pulmonary embolism

    90 days

  • 90 day risk of deep venous thrombosis

    90 days

  • +4 more secondary outcomes

Other Outcomes (6)

  • Pregnancy loss

    9 months

  • Stillbirth

    9 months

  • Antepartum bleeding

    9 months

  • +3 more other outcomes

Study Arms (2)

Dalteparin

ACTIVE COMPARATOR
Drug: Tinzaparin profiled syringe

Tinzaparin

ACTIVE COMPARATOR
Drug: Dalteparin Prefilled Syringe

Interventions

Dalteparin Prefilled SyringeDRUG

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
Tinzaparin profiled syringeDRUG

Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.

Dalteparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients with indication for low molecular weight heparin

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Amager-Hvidovre Hospital

Copenhagen, Denmark

RECRUITING

Frederiksberg and Bispebjerg Hospital

Copenhagen, Denmark

RECRUITING

Rigshospitalet

Copenhagen, Denmark

RECRUITING

Herlev and Gentofte Hospital

Herlev, 2730, 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

MeSH Terms

Conditions

Venous Thromboembolism

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Central Study Contacts

Kasper Iversen, Professor, MD

CONTACT

+ 45 28712753Kasper.Karmark.Iversen@regionh.dk

Lars Køber, Professor, MD

CONTACT

+ 45 35458525lars.koeber01@regionh.dk

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

March 27, 2023

First Posted

August 31, 2023

Study Start

March 23, 2023

Primary Completion

March 23, 2025

Study Completion

March 23, 2025

Last Updated

August 31, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

DK(9)