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RECRUITING
NCT06667999
PHASE4

The Intensive Care Platform Trial

Sponsor: Anders Perner

View on ClinicalTrials.gov

Summary

Among critically ill patients, many die, and many of the survivors and their family members struggle for years with reduced quality of life. Critically ill patients are treated in intensive care units (ICUs). Here, they receive life support, e.g., mechanical ventilation and advanced support of the circulation (heart and blood vessels) and kidneys. In addition, ICU patients receive many other treatments. It is, however, uncertain if all the treatments provide value for the patients. The desirable effects of many treatments are uncertain, and some may be wasteful or even harmful. Clinical trials are necessary to validly assess the desirable and undesirable effects of different treatments. However, conventional clinical trials have limitations: * They typically only assess a single question related to a single comparison of treatments at a time. * They are often not very flexible, including with regards to the number of participants needed, and this increases the risk that a trial will end up as inconclusive. * There is no or limited re-use or sharing of infrastructure across trials, leading to duplicate work and resource use. * Trial participants do usually not benefit from the obtained knowledge before the trial concludes. * Involvement of patients, family members, and other stakeholders is typically limited, which may decrease the relevance of the questions addressed. With the Intensive Care Platform Trial (INCEPT), we aim to tackle these challenges by establishing a flexible platform trial that continuously learns from the obtained results. The platform trial may run forever with simultaneous and continuous assessment of many treatments. INCEPT will continuously learn from the accrued data and use these to improve the treatment of both participating and future patients. With INCEPT, we are also building a framework for thorough and extensive involvement of key stakeholders, including patients and family members. INCEPT will improve the way clinical trials are done and increase the probabilities that treatments are improved. This will: * Directly improve outcomes for ICU patients. * Relieve a strained healthcare system by discarding inefficient or harmful treatments. * Ensure that new treatments are beneficial or cost-effective before implementation. * Lower the costs and burdens of assessing more treatments in the critically ill.

Official title: The Intensive Care Platform Trial (INCEPT)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10000

Start Date

2025-06-26

Completion Date

2035-12

Last Updated

2026-03-19

Healthy Volunteers

No

Interventions

DRUG

Albumin

Albumin should be used for the following indications: 1. During circulatory failure in addition to crystalloids (resuscitation). 2. For substitution in case of: suspected or overt albumin loss OR P-albumin levels below or equal to 25 g/L. Decisions around timing, volume, and concentration of albumin, and its use for other indications, are at the clinician's discretion. P-albumin should be measured according to local practice.

OTHER

No albumin use

Albumin should not be used. In case of the following special circumstances, albumin may be considered: 1. Large ascites drainage (i.e., equal to or more than 1 L tapped) 2. Spontaneous bacterial peritonitis 3. Hepatorenal syndrome.

DRUG

LMWH in weight-adjusted dose

Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a weight-adjusted dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.

DRUG

LMWH in fixed low dose

Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed low dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.

DRUG

LMWH in fixed intermediate dose

Patients with indication for thromboprophylaxis receive low-molecular-weight heparin (LMWH) in a fixed intermediate dose during their ICU stay. The treating clinician may decide to adjust or withhold one or more doses in case of acute and/or chronic kidney injury, renal replacement therapy, thrombocytopenia, invasive procedures, use of thrombolysis, and active (major) bleeding.

Locations (21)

Anaesthesia, Hospital Sønderjylland

Aabenraa, Denmark

Department of Anaesthesia and Intensive Care, Aalborg University Hospital

Aalborg, Denmark

Department of Intensive Care Nord , Aarhus University Hospital

Aarhus, Denmark

Department of Intensive Care Øst, Aarhus University Hospital

Aarhus, Denmark

Department of Cardiothoracic Anaesthesia and Intensive care, Copenhagen Universisty Hospital - Rigshospitalet

Copenhagen, Denmark

Department of Intensive Care, Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

Neuroanaesthesiology, Copenhagen University Hospital - Rigshospitalet

Copenhagen, Denmark

Department of anesthesiology and intensive care, Bispebjerg-Frederiksberg Hospital

Copenhagen, Denmark

Esbjerg Hospital

Esbjerg, Denmark

Department of Anesthesiology and Intensive Care, Copenhagen University Hospital Herlev

Herlev, Denmark

Department of Anaesthesiology and Intensive Care, Gødstrup Hospital

Herning, Denmark

Department of Anaesthesia and Intensive Care Medicine, Copenhagen University Hospital - North Zealand

Hillerød, Denmark

Anaesthesiology and Intensive Care, Amager and Hvidovre Hospital

Hvidovre, Denmark

Department of Anesthesia and intensive care medicine, Kolding Hospital

Kolding, Denmark

Department of Anesthesia, Zealand University Hospital

Køge, Denmark

Anesthesiology (ICU), Zealand University Hospital, Nykøbing Falster

Nykøbing Falster, Denmark

Department of Anesthesiology and Intensive Care, Odense University Hospital

Odense, Denmark

Operation og Intensiv, Regional Hospital Randers

Randers, Denmark

Intensive care, Slagelse Hospital

Slagelse, Denmark

Department. of Anesthesiology and Intensive Care Medicine

Svendborg, Denmark

Department of Anaesthesiology and Intensive Care, Regional Hospital Viborg

Viborg, Denmark