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The Intensive Care Platform Trial
Sponsor: Anders Perner
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
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.
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.
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.
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.
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