Cluster randomised trial of blood thinners

2022-502402-32-00 Therapeutic use (Phase IV) Ended

End 25 Mar 2025 · Status Ended · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ended
Participants planned 65,000
Countries 1
Sites 1

Venous thromboembolism

To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring bleeding during admission or death within 30 days in patients with indication for low molecular weight heparins, compared with one of the other low molecular weight heparins

Key facts

Sponsor
Rigshospitalet
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Cardiovascular Diseases [C14]
Trial duration
completed 25 Mar 2025
Decision date (initial)
2023-01-18
Transition trial
No
Low-intervention
Yes
Rare-disease indication
No
Vulnerable population
Yes
Funding sources
Herlev and Gentofte Hospital, kardiologisk afdeling og akutafdelingen

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Prophylaxis, Efficacy, Therapy, Safety

To evaluate whether treatment with any of the low molecular weight heparins will increase the risk of bleeding requiring bleeding during admission or death within 30 days in patients with indication for low molecular weight heparins, compared with one of the other low molecular weight heparins

Secondary objectives 1

  1. To investigate the comparable risk in patients treated with enoxaparin, dalteparin or tinzaparin regarding: 1. All-cause 30 day mortality 2. All-cause 365 day mortality 3. Blood transfusion during admission 4. Pulmonary embolism at 30 days 5. Heparin induced thrombocytopenia 6. Liver failure 7. Length of hospital admission 8. Days alive out of hospital

Conditions and MedDRA coding

Venous thromboembolism

VersionLevelCodeTermSystem organ class
21.1 LLT 10066899 Venous thromboembolism 10047065
21.0 PT 10037377 Pulmonary embolism 100000004855
21.1 LLT 10049909 Venous thromboembolism prophylaxis 10042613

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

  1. Patients that will be included in the study will be patients that are admitted to the hospital and who has indication for treatment with a low molecular weight heparin. Patients will only be included the first time they are admitted in the period the study run.

Exclusion criteria 1

  1. • Patients under the age of 18 • Patients that incapable of understanding the written material received • Patients that after being informed in writing choses not participate

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Major bleeding requiring blood transfusion and all-cause mortality at 30 days

Secondary endpoints 1

  1. 1. All-cause 30 day mortality 2. All-cause 365 day mortality 3. Blood transfusion during admission 4. Pulmonary embolism at 30 days 5. Heparin induced thrombocytopenia 6. Liver failure 7. Length of hospital admission 8. Days alive out of hospital

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Tinzaparin

SCP236674 · ATC

Active substance
Tinzaparin
Route of administration
SUBCUTANEOUS INJECTION
Max daily dose
175 IU/Kg iu/kilogram
Max total dose
175 IU/Kg iu/kilogram
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
B01AB10 — TINZAPARIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Dalteparin Sodium

SCP2053644 · ATC

Active substance
Dalteparin Sodium
Route of administration
SUBCUTANEOUS USE
Max daily dose
200 IU/Kg iu/kilogram
Max total dose
200 IU/Kg iu/kilogram
Max treatment duration
52 Week(s)
Authorisation status
Authorised
ATC code
B01AB04 — DALTEPARIN
Marketing authorisation
-
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Blegdamsvej 9
City
Copenhagen Oe
Postcode
2100
Country
Denmark

Scientific contact point

Organisation
Rigshospitalet
Contact name
Lars Koeber

Public contact point

Organisation
Rigshospitalet
Contact name
Caroline Sindet Clausen

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ended 65,000 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ended
Region Hovedstadens
Department of Emergency Medicine and department of cardiology, Kongens Vaenge 2, 3400, Hilleroed

Application history

5 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2022-11-07 Denmark Acceptable
2023-01-17
 2023-01-18
2 SUBSTANTIAL MODIFICATION SM-2 2023-03-09
3 SUBSTANTIAL MODIFICATION SM-3 2023-03-09 Denmark Acceptable
2023-03-20
 2023-03-21
4 SUBSTANTIAL MODIFICATION SM-5 2023-04-18 Denmark Acceptable
2023-05-26
 2023-05-26
5 SUBSTANTIAL MODIFICATION SM-8 2024-04-03 Denmark Acceptable
2024-05-30
 2024-05-31

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