Clinical trial • Not applicable • Other

DALTEPARIN SODIUM for Acute critical illness

Not applicable trial of DALTEPARIN SODIUM for Acute critical illness. 20000 participants.

Overview

Trial Therapeutic Area
Other
Trial Disease
Acute critical illness
Trial Stage
Not applicable
Drug Modality
Other|Peptide/protein/enzyme

Key dates

Initial CTIS Submission Date
07-11-2024
First CTIS Authorization Date
18-02-2025

Trial design

Not applicable trial in Denmark, Finland, Iceland and others.

Target Sample Size
20000
Trial Duration For Participant
180

Eligibility

Recruits 20000 Vulnerable population selected: critically ill adult ICU patients who may lack capacity. Consent/assent handling: subject information and consent forms exist for study participants and for next of kin/relatives/legal representatives (e.g., documents titled 'next of kin' and 'Relative' consent forms); consent is obtained from the participant if capable, otherwise via next of kin/legal representative as reflected by the available 'next of kin' and 'relative' ICF documents..

Vulnerable Population
Vulnerable population selected: critically ill adult ICU patients who may lack capacity. Consent/assent handling: subject information and consent forms exist for study participants and for next of kin/relatives/legal representatives (e.g., documents titled 'next of kin' and 'Relative' consent forms); consent is obtained from the participant if capable, otherwise via next of kin/legal representative as reflected by the available 'next of kin' and 'relative' ICF documents.

Inclusion criteria

  • {"criterion_text":"- Adult patient (≥18 years old) acutely admitted to the ICU.\n- Eligible for at least one active domain."}

Exclusion criteria

  • {"criterion_text":"- Informed consent following inclusion expected to be unobtainable (e.g., known previous objections to participation).\n- Patient is under coercive measures (e.g., ongoing involuntary hospital stay or under the jurisdiction of correctional authorities)."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Each domain in INCEPT will use one of the outcomes listed below under 'secondary end points' as the primary - the primary outcome will thus differ between domains, but always be one of the secondary outcomes (the core outcome set defined in the core protocol).","definition_or_measurement_approach":"Primary outcome is domain-specific and will be chosen from the listed secondary endpoints (the core outcome set). Measurement approach depends on the selected secondary outcome for that domain (examples of secondary outcomes include all-cause mortality at fixed timepoints, days alive without life support at specified days, EQ-5D-5L at day 180, cognitive assessment at day 180)."}

Secondary endpoints

  • {"endpoint_text":"- All-cause 30-day mortality\n- All-cause 90-day mortality\n- All-cause 180-day mortality\n- Days alive without life support at day 30\n- Days alive without life support at day 90\n- Days alive out of hospital at day 30\n- Days alive out of hospital at day 90\n- Days free of delirium at day 30\n- EQ-5D-5L index values (health-related quality of life) at day 180\n- EQ VAS (health-related quality of life) at day 180\n- Cognitive function at day 180 (Montreal Cognitive Assessment test 5-minute version, v2.1 [“Mini MoCA”])\n- One or more domain-specific safety outcomes","definition_or_measurement_approach":"All-cause mortality: vital status assessed at day 30, 90, 180. Days alive without life support: count of days patient is alive and not receiving life support up to day 30 or day 90. Days alive out of hospital: number of days alive and not hospitalised up to day 30 or day 90. Days free of delirium at day 30: days without delirium up to day 30. EQ-5D-5L index and EQ VAS: patient-reported health-related quality of life measured at day 180 using EQ-5D-5L and EQ VAS instruments. Cognitive function: assessed at day 180 using the Montreal Cognitive Assessment 5-minute version (Mini MoCA v2.1). Domain-specific safety outcomes: safety events defined per domain (as applicable)."}

Recruitment

Planned Sample Size
20000
Recruitment Window Months
129
Consent Approach
Informed consent: participant consent is obtained when the patient has capacity. For participants lacking capacity (critically ill ICU patients), consent procedures include next of kin / legal representative consent as indicated by multiple 'next of kin' and 'relative' consent documents in the application. There are specific ICFs for study participants and for next of kin/relatives, and domain-specific consent forms (e.g., Albumin, Thromboprophylaxis). Country-specific ICF and recruitment documents are available (documents listed for Denmark, Sweden, Netherlands, Iceland, Finland).

Geography

Total Number Of Sites
32
Total Number Of Participants
100000

Denmark

Latest Decision Or Authorization Date
18-02-2025
Number Of Sites
19
Number Of Participants
20000

Sites

Site Name
Esbjerg Og Grindsted Sygehus
Department Name
Department of Anesthesiology and Intensive Care
Contact Person Name
Anders Storgaard
Contact Person Email
anders.storgaard@rsyd.dk
Site Name
Region Midtjylland
Department Name
Department of Intensive Care
Contact Person Name
Marianne Lauridsen Vang
Contact Person Email
marivang@rm.dk
Site Name
Aalborg University Hospital
Department Name
Department of Anesthesia and Intensive Care
Contact Person Name
Bodil Steen Rasmussen
Contact Person Email
bodil.steen.rasmussen@rn.dk
Site Name
Region Midtjylland
Department Name
Department of Intensive Care
Contact Person Name
Asger Granfeldt
Contact Person Email
asgegran@rm.dk
Site Name
Copenhagen University Hospital
Department Name
Department of Anestesiology and Intensive Care
Contact Person Name
Nanna Reiter
Contact Person Email
nanna.reiter@regionh.dk
Site Name
Rigshospitalet
Department Name
Department of Intensive Care
Contact Person Name
Anders Perner
Contact Person Email
anders.perner@regionh.dk
Site Name
Copenhagen University Hospital
Department Name
Department of Neuroanaesthesiology
Contact Person Name
Kirsten Moeller
Contact Person Email
kirsten.moeller.01@regionh.dk
Site Name
Copenhagen University Hospital
Department Name
Department of Intensive Care
Contact Person Name
Anne Sofie Andreasen
Site Name
Region Sjaelland
Department Name
Department of Intensive Care
Contact Person Name
Hans Fjeldsoe-Nielsen
Contact Person Email
hafj@regionsjaelland.dk
Site Name
Region Midtjylland
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Iben Strøm Darfelt
Contact Person Email
ibedar@rm.dk
Site Name
Lillebaelt Hospital
Department Name
Department of Anesthesia and Intensive Care Medicine
Contact Person Name
Anne Craveiro Brøchner
Site Name
Region Midtjylland
Department Name
Department of Anaestesiology and Intensive Care
Contact Person Name
Christoffer Grant Sølling
Contact Person Email
chrisl@rm.dk
Site Name
Region Sjaelland
Department Name
Department of Anesthesia
Contact Person Name
Lars Peter Kloster Andersen
Contact Person Email
lpka@regionsjaelland.dk
Site Name
Sygehus Soenderjylland Soenderborg
Department Name
Department of Anesthesia
Contact Person Name
Rajesh Prabhakar Bhavsar
Site Name
Hvidovre Hospital
Department Name
Department of Intensive Care
Contact Person Name
Ronni Plovsing
Site Name
Copenhagen University Hospital
Department Name
Department of Cardiothoracic Anaesthesia and Intensive Care
Contact Person Name
Peter Buhl Hjortrup
Contact Person Email
peter.buhl.hjortrup@regionh.dk
Site Name
Region Midtjylland
Department Name
Department of Intensive Care, Nord
Contact Person Name
Klaus Ulrik Koch
Contact Person Email
klaukoch@rm.dk
Site Name
Odense University Hospital
Department Name
Department of Anesthesiology and Intensive Care
Contact Person Name
Jens Michelsen
Contact Person Email
jens-michelsen3@rsyd.dk
Site Name
Odense University Hospital
Department Name
Dept. of Anesthesiology and Intensive Care Medicine
Contact Person Name
Peter Martin Hansen
Contact Person Email
peter.martin.hansen@rsyd.dk

Finland

Latest Decision Or Authorization Date
18-03-2026
Number Of Sites
4
Number Of Participants
20000

Sites

Site Name
Pirkanmaan hyvinvointialue
Department Name
Anaesthesiology and Intensive Care Medicine
Contact Person Name
Johanna Hastbacka
Contact Person Email
johanna.hastbacka@pirha.fi
Site Name
Pohjois-Savon hyvinvointialue
Department Name
Department of Anaesthesiology and Intensive Care
Contact Person Name
Matti Reinikainen
Site Name
Wellbeing Services County Of Central Finland
Department Name
rtment of Anesthesiology and Intensive Care
Contact Person Name
Nina Inkinen
Contact Person Email
nina.inkinen@hyvaks.fi
Site Name
HUS-yhtymae
Department Name
Perioperative and Intensive Care
Contact Person Name
Erika Wilkman
Contact Person Email
Erika.wilkman@hus.fi

Iceland

Latest Decision Or Authorization Date
30-03-2026
Number Of Sites
1
Number Of Participants
20000

Sites

Site Name
Landspitali
Department Name
Department of Anaesthesiology and Critical Care Medicine
Contact Person Name
Martin Ingi Sigurðsson
Contact Person Email
Martin@landspitali.is

Sweden

Latest Decision Or Authorization Date
27-02-2026
Number Of Sites
3
Number Of Participants
20000

Sites

Site Name
Danderyds Sjukhus AB
Department Name
Department of Anaesthesia and Intensive Care
Contact Person Name
Maria Cronhjort
Site Name
Karolinska University Hospital
Department Name
Perioperativ Medicin och Intensivvård
Contact Person Name
Johan Mårtensson
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Intensive and Perioperative Care
Contact Person Name
Fredrik Sjovall
Contact Person Email
Fredrik.sjovall@med.lu.se

Netherlands

Latest Decision Or Authorization Date
20-03-2026
Number Of Sites
5
Number Of Participants
20000

Sites

Site Name
Antonius ziekenhuis Sneek
Department Name
Anesthesiology and Intensive Care
Contact Person Name
Anne-Mette Sauër
Contact Person Email
a.sauer@mijnantonius.nl
Site Name
Universitair Medisch Centrum Groningen
Department Name
Critical Care
Contact Person Name
Frederik Keus
Contact Person Email
f.keus@umcg.nl
Site Name
Stichting Martini Ziekenhuis
Department Name
Intensive Care
Contact Person Name
Marijn Johannes Boer
Contact Person Email
boermj@mzh.nl
Site Name
Ziekenhuis Nij Smellinghe
Department Name
Anesthesiology and Intensive Care
Contact Person Name
Maarten van Hasselt
Contact Person Email
h.mijle@nijsmellinghe.nl
Site Name
Academisch Ziekenhuis Maastricht
Department Name
Intensive Care Medicine
Contact Person Name
Bas C.T. van Bussel
Contact Person Email
bas.van.bussel@mumc.nl

Sponsor

Primary sponsor

Full Name
Rigshospitalet
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Fragmin, injektionsvæske, opløsning i fyldt injektionssprøjte med nålebeskytter
Active Substance
DALTEPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Maximum Dose
10000 IU (max daily dose amount)
Investigational Product Name
Human Albumin ”CSL Behring”, infusionsvæske, opløsning 20 %
Active Substance
HUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
10 l (max daily dose amount)
Investigational Product Name
Innohep, injektionsvæske, opløsning i fyldt injektionssprøjte 2.500 anti-Xa IE
Active Substance
TINZAPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Maximum Dose
8000 IU (max daily dose amount)
Investigational Product Name
Fraxiparine 2.850 IE/ 0,3 ml oplossing voor injectie
Active Substance
NADROPARIN CALCIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Maximum Dose
7600 IU (max daily dose amount)
Investigational Product Name
Enoxaparin "Becat", injektionsvæske, opløsning i fyldt injektionssprøjte
Active Substance
ENOXAPARIN SODIUM
Modality
Other
Routes Of Administration
SUBCUTANEOUS INJECTION
Route
SUBCUTANEOUS INJECTION
Authorisation Status
Authorised
Maximum Dose
100 mg (max daily dose amount)
Investigational Product Name
Human Albumin ”CSL Behring”, infusionsvæske, opløsning 5 %
Active Substance
HUMAN PLASMA PROTEINS WITH NOT LESS THAN 96% ALBUMIN
Modality
Peptide/protein/enzyme
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised
Maximum Dose
10 l (max daily dose amount)

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