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Study of Low Molecular Weight Heparins (DANHEP)

Primary Purpose

Anticoagulant, Venous Thromboembolism, Prophylaxis

Status
Recruiting
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Dalteparin Prefilled Syringe
Tinzaparin profiled syringe
Sponsored by
Herlev Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anticoagulant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Amager-Hvidovre HospitalRecruiting
  • Frederiksberg and Bispebjerg HospitalRecruiting
  • RigshospitaletRecruiting
  • Herlev and Gentofte HospitalRecruiting
  • Nordsjællands HospitalRecruiting
  • Nykøbing Falster HospitalRecruiting
  • Næstved, Ringsted, Slagelse HospitalRecruiting
  • Roskilde, Køge HospitalRecruiting
  • Bornholm HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dalteparin

Tinzaparin

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

30-day all-cause mortality
Risk of all-cause mortality within 30 days of administering one of the studied drugs
365-day all-cause mortality
Risk of all-cause mortality within 365 days of administering one of the studied drugs
Blood transfusion during admission
Blood transfusion defined from use of blood products
90 day risk of pulmonary embolism
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
90 day risk of deep venous thrombosis
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Heparin induced thrombocytopenia
Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies
Liver failure
Risk of liver failure defined by ALAT 3X upper limit of normal
Length of hospital admission
Length of hospital admission
Days alive out of hospital
Days alive out of hospital

Full Information

First Posted
March 27, 2023
Last Updated
August 29, 2023
Sponsor
Herlev Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06020560
Brief Title
Study of Low Molecular Weight Heparins
Acronym
DANHEP
Official Title
Cluster-randomized Trial of Low Molecular Weight Heparins - Directly Through EPIC
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 23, 2023 (Actual)
Primary Completion Date
March 23, 2025 (Anticipated)
Study Completion Date
March 23, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Herlev Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anticoagulant, Venous Thromboembolism, Prophylaxis, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dalteparin
Arm Type
Active Comparator
Arm Title
Tinzaparin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Dalteparin Prefilled Syringe
Intervention Description
Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
Intervention Type
Drug
Intervention Name(s)
Tinzaparin profiled syringe
Intervention Description
Patients will via a software module (Through a patient journal system) be allocated to either dalteparin or tinzaparin. Clusters are timeframes of 1 hour.
Primary Outcome Measure Information:
Title
30-day all-cause mortality and bleeding requiring blood transfusion
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
30-day all-cause mortality
Description
Risk of all-cause mortality within 30 days of administering one of the studied drugs
Time Frame
30 days
Title
365-day all-cause mortality
Description
Risk of all-cause mortality within 365 days of administering one of the studied drugs
Time Frame
365 days
Title
Blood transfusion during admission
Description
Blood transfusion defined from use of blood products
Time Frame
90 days
Title
90 day risk of pulmonary embolism
Description
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Time Frame
90 days
Title
90 day risk of deep venous thrombosis
Description
Risk of pulmonary embolism within 90 days of administering one of the drugs studied
Time Frame
90 days
Title
Heparin induced thrombocytopenia
Description
Risk of heparin induced thrombocytopenia defined by; thrombocytes less than 150 x 109/l and presence of HIT antibodies
Time Frame
90 days
Title
Liver failure
Description
Risk of liver failure defined by ALAT 3X upper limit of normal
Time Frame
90 days
Title
Length of hospital admission
Description
Length of hospital admission
Time Frame
Admission time (up to 1 year from inclusion measured in days)
Title
Days alive out of hospital
Description
Days alive out of hospital
Time Frame
Time out of hospital (up to 1 year from inclusion measured in days)
Other Pre-specified Outcome Measures:
Title
Pregnancy loss
Description
Risk of pregnancy loss during treatment with either of the two drugs studied
Time Frame
9 months
Title
Stillbirth
Description
Risk of stillbirth during treatment with either of the two drugs studied
Time Frame
9 months
Title
Antepartum bleeding
Description
Risk of antepartum bleeding during treatment with either of the two drugs studied
Time Frame
9 months
Title
Postpartum bleeding
Description
Risk of postpartum bleeding during treatment with either of the two drugs studied
Time Frame
up to 365 days
Title
Placental complications
Description
Risk of placental complications (Abruptio placenta, placenta prevue) during treatment with either of the two drugs studied
Time Frame
9 months
Title
Preeclampsia
Description
Risk of preeclampsia and eclampsia during treatment with either of the two drugs studied
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kasper Iversen, Professor, MD
Phone
+ 45 28712753
Email
Kasper.Karmark.Iversen@regionh.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Lars Køber, Professor, MD
Phone
+ 45 35458525
Email
lars.koeber01@regionh.dk
Facility Information:
Facility Name
Amager-Hvidovre Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henriette Svarre, Professor, MD
Email
Henriette.Svarre.Nielsen@regionh.dk
Facility Name
Frederiksberg and Bispebjerg Hospital
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Søren Overgaard, Professor, MD
Facility Name
Rigshospitalet
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lars Køber, Professor, MD
Email
Lars.Koeber.01@regionh.dk
Facility Name
Herlev and Gentofte Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kasper K Iversen, MD, DMsc
Email
Kasper.Karmark.Iversen@regionh.dk
Facility Name
Nordsjællands Hospital
City
Hillerød
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten Bestle, Professor, MD
Email
Morten.Bestle@regionh.dk
Facility Name
Nykøbing Falster Hospital
City
Nykøbing Falster
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacob Fyhring Mortensen, MD
First Name & Middle Initial & Last Name & Degree
Jmot@regionsjaelland.dk
Facility Name
Næstved, Ringsted, Slagelse Hospital
City
Næstved
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Stig Jørgensen, MD
Email
henjor@regionsjaelland.dk
Facility Name
Roskilde, Køge Hospital
City
Roskilde
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lasse Bremholm
Email
labha@regionsjaelland.dk
Facility Name
Bornholm Hospital
City
Rønne
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Kaiser
Email
diana.utech.kaiser@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD
No

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Study of Low Molecular Weight Heparins

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