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

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What is this study about?

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.

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 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 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 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

5 180-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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Sydvestjysk Sygehus Esbjerg Denmark
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Landspitali Reykjavik Iceland
Danderyds Sjukhus AB Danderyd Sweden
Central Finland Hospital District Central Finland Hospital Nova Jyvaskyla Finland
Ziekenhuis Nij Smellinghe Drachten The Netherlands
Odense University Hospital Odense Denmark
Region Skane Skanes Universitetssjukhus Lund Sweden
Karolinska University Hospital Solna Sweden
Slagelse Hospital Slagelse Denmark
Sygehus Lillebaelt Vejle Sygehus Vejle Denmark
Aalborg University Hospital Aalborg Denmark
Region Midtjylland Aarhus Denmark
Rigshospitalet Copenhagen Denmark
Sygehus Soenderjylland Soenderborg Aabenraa Denmark
Pohjois-Savon hyvinvointialue Kuopio Finland
Pirkanmaan hyvinvointialue Tampere Finland
Roskilde University Roskilde Denmark
Region Sjaelland Holbæk Denmark
Umfsmoimzzse Mxcbaxt Cngpfjw Gxmmhwbag Groningen The Netherlands
Svqqhjgmm Mdvukua Zbcquvwuwi Groningen The Netherlands
Hoywifei Hzlqyqls Hvidovre Denmark
Abqhlceq zwzheyulkm Shpvx Sneek The Netherlands
Hhwxlblt Hfvdvrqy Hillerød Denmark
Hafwkgog Ubhnnvdaqq Cdmkaey Hehoaiqf Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.03.2025
Finland Finland
Not yet recruiting
01.03.2025
Iceland Iceland
Not yet recruiting
01.03.2025
Sweden Sweden
Not yet recruiting
01.03.2025
The Netherlands The Netherlands
Not yet recruiting
01.03.2025

Trial locations

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.

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 ID:
2024-516208-41-00
NCT ID:
NCT06667999
Trial Phase:
Therapeutic confirmatory (Phase III)

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