NCT05245253

Brief Summary

The overall aim is to examine the impact of trauma and critical illness on the brain, peripheral immune system and cognition. This is a prospective study where a study group exposed to trauma and intensive care will be be examined with consecutive PET imaging, EEG, biomarkers and cognitive testing within 3 weeks of the trauma, after 3 months and finally after 12 months. The study group will consist of twenty trauma patients treated in the intensive care unit.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2021

Completed
1 year until next milestone

First Posted

Study publicly available on registry

February 17, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

2.4 years

First QC Date

February 17, 2021

Last Update Submit

December 14, 2022

Conditions

Cognitive DysfunctionCritical IllnessTrauma

Outcome Measures

Primary Outcomes (2)

  • Neuroinflammation

    The trajectory of neuroinflammation as measured by repeated PET-examinations. More specifically, the probe targeting the translocator protein indicates microglia-activation as a sign of inflammatory activation. The change in binding capacity of the probe will be measured, generating a difference in signal in the regions of interest.

    3 weeks-12 months post trauma

  • Cognitive dysfunction

    Cognitive function will be evaluated with Cambridge Neuropsychological Automated Battery (CANTAB) with five different tests at three timepoints. A z-score will be calcualted for each test and then aggregated into a total z-score for the entire test.

    3 weeks-12 months post trauma

Study Arms (1)

Trauma patients

Trauma patients 20-60 years of age

Radiation: Positron Emission tomography

Interventions

Positron Emission tomographyRADIATION

Patients will be tested with PET-examination at 3 weeks, 3 months and 1 year after the trauma

Trauma patients

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Trauma patients in the ICU

You may qualify if:

  • Patients 20-60 years of age.
  • Trauma with an ISS score of ≥15
  • Informed consent

You may not qualify if:

  • Patient´s refusal to participate in the trial
  • Any traumatic brain or spinal injury prior to admission
  • Disabling neuropsychiatric disorder (dementia-diagnosis, Mb Alzheimer, Mb Parkinson, schizophrenia or severe mental depression prior to ICU admission)
  • Any preadmission history of stroke with neurological sequelae
  • Co-morbidities prior to ICU admission such as severe cardiac, hepatic, hematological or renal impairment
  • Terminal phase of chronic disease or malignancy
  • High-dose steroid treatment before ICU admission or during ICU care
  • Presumed uncooperativeness or legal incapacity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska University Hospital, Perioperative Medicine and Intensive Care

Stockholm, 17176, Sweden

RECRUITING

Related Publications (2)

  • Forsberg A, Cervenka S, Jonsson Fagerlund M, Rasmussen LS, Zetterberg H, Erlandsson Harris H, Stridh P, Christensson E, Granstrom A, Schening A, Dymmel K, Knave N, Terrando N, Maze M, Borg J, Varrone A, Halldin C, Blennow K, Farde L, Eriksson LI. The immune response of the human brain to abdominal surgery. Ann Neurol. 2017 Apr;81(4):572-582. doi: 10.1002/ana.24909. Epub 2017 Apr 11.

    PMID: 28253549RESULT

  • Owen DR, Yeo AJ, Gunn RN, Song K, Wadsworth G, Lewis A, Rhodes C, Pulford DJ, Bennacef I, Parker CA, StJean PL, Cardon LR, Mooser VE, Matthews PM, Rabiner EA, Rubio JP. An 18-kDa translocator protein (TSPO) polymorphism explains differences in binding affinity of the PET radioligand PBR28. J Cereb Blood Flow Metab. 2012 Jan;32(1):1-5. doi: 10.1038/jcbfm.2011.147. Epub 2011 Oct 19.

    PMID: 22008728RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood from subjects

MeSH Terms

Conditions

Cognitive DysfunctionCritical IllnessWounds and Injuries

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Lars I Eriksson, Professor

    Karolinska Institutet

    STUDY CHAIR

Central Study Contacts

Jessica Kåhlin, MD, PhD

CONTACT

+46707295456jessica.kahlin@sll.se

Elias Jokhadar, MD

CONTACT

+46706121264elias.jokhadar@regionstockholm.se

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Attending in ICU

Study Record Dates

First Submitted

February 17, 2021

First Posted

February 17, 2022

Study Start

April 1, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2025

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations

SE(1)