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Evaluation of enoxaparin, dalteparin, nadroparin, tinzaparin and human albumin in adults admitted to intensive care unit with acute critical illness

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial aims to evaluate different treatments for patients with acute critical illness who require admission to the intensive care unit. The study will test several medications that are commonly used in intensive care, including different types of blood-thinning medications (enoxaparin, dalteparin, nadroparin, and tinzaparin) given by injection under the skin, as well as human albumin solutions given through a vein.

The study uses a platform design, which means it can evaluate multiple treatments at the same time. Patients will receive one or more of the study medications depending on their specific medical needs. The treatments will be given for up to 90 days while patients are in the intensive care unit.

The study will track various outcomes to determine how well the treatments work, including how long patients survive, how many days they spend without needing life support machines, how many days they spend out of the hospital, and their quality of life after treatment. The study will also monitor patients for any side effects from the medications.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial admission to intensive care

    Your admission to the intensive care unit (ICU) begins after meeting eligibility criteria as an adult patient (18 years or older)

    Medical staff will evaluate your condition to determine which treatment domains are suitable for your situation

  2. Step 2

    Treatment administration

    You may receive one or more of the following medications based on your treatment needs:

    - Injection medications (enoxaparin, dalteparin, nadroparin, or tinzaparin) given under the skin

    - Infusion medications (human albumin solutions) given through an intravenous line

  3. Step 3

    30-day monitoring period

    Medical staff will track your progress for the first 30 days, including:

    - Survival status

    - Days without requiring life support

    - Days spent outside the hospital

    - Presence of confusion or altered mental state (delirium)

  4. Step 4

    90-day follow-up

    Your health status will be evaluated at 90 days, measuring:

    - Survival status

    - Total days without life support

    - Total days spent outside the hospital

  5. Step 5

    180-day assessment

    Final evaluation at 180 days will include:

    - Survival status

    - Quality of life assessment using standardized questionnaires

    - Brief cognitive function test to assess mental abilities

Who can join the trial?

5 criteria

  • Must be 18 years or older
  • Must require urgent admission to the Intensive Care Unit (ICU) - a specialized hospital department that provides continuous monitoring and treatment for critically ill patients
  • Must qualify for at least one active treatment area in the study
  • Both men and women can participate
  • Must be experiencing an acute critical illness - a severe medical condition that requires immediate intensive care treatment

Who cannot join the trial?

9 criteria

  • Age below 18 years old (minors are not eligible)
  • Patients not admitted to an intensive care unit (a specialized hospital department that provides intensive medical care)
  • Patients who are not in a state of acute critical illness (severe, sudden medical condition requiring immediate intensive medical care)
  • Patients who are unable to provide informed consent and do not have a legally authorized representative to provide consent on their behalf
  • Patients who have previously participated in this clinical trial
  • Patients who are currently participating in another interventional clinical trial that could interfere with this study
  • Patients who are pregnant or breastfeeding, unless specifically allowed by individual intervention protocols
  • Patients with known allergies or hypersensitivity to any of the study medications
  • Patients with medical conditions that would make participation unsafe or could interfere with the study results
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Investigated drugs

Based on the provided source data, there are no specific medications or therapies listed in the trial information. The trial appears to be a platform study that will assess various interventions used in intensive care units, but the specific medications or treatments are not detailed in the provided data. Without specific medication or therapy information, I cannot provide descriptions of individual treatments.

What is already known about the treatment

Based on the provided clinical trial data, there are no specific medications listed to describe. The trial (INCEPT) appears to be a platform study focusing on evaluating various interventions used in intensive care units, but no specific medications are mentioned in the source data. Without specific medication names from the trial data, I cannot create the requested medication descriptions in the format you specified. If you would like medication descriptions, please provide the specific medications being studied in the trial, and I will be happy to describe them in the requested format.

Investigated diseases

  • Critical Illness

    A severe medical condition that causes organ dysfunction and requires intensive care treatment. Critical illness develops when one or more vital organ systems begin to fail, leading to severe physiological instability. The condition often involves respiratory failure, circulatory problems, or other major organ dysfunction. Critical illness can develop suddenly (acute) or as a complication of existing medical conditions. The body's stress response during critical illness can affect multiple organ systems simultaneously. Patients with critical illness require constant monitoring and support of vital functions.

  • Delirium

    A serious disturbance in mental abilities that results in confused thinking and reduced awareness of the environment. Delirium causes changes in attention, awareness, and cognition that typically develop over a short period. People with delirium may experience hallucinations, disorientation, and changes in sleep patterns. The condition can fluctuate throughout the day, with symptoms often worsening during the night. Delirium is especially common in intensive care settings.

  • Cognitive Dysfunction

    A condition characterized by difficulties with memory, learning, concentration, and decision making. It involves problems with various mental abilities including thinking, memory, and reasoning. Cognitive dysfunction can affect daily activities and social interactions. The severity can range from mild to severe, affecting different aspects of mental function. The condition can develop gradually or suddenly, depending on the underlying cause.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516208-41-00Estimated enrolment142 000 patientsSponsorRegion Hovedstaden

sourced from the EU Clinical Trials Register and site verification

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