NCT03913065

Brief Summary

The European Resuscitation Council (ERC) and the European Society of Intensive Care Medicine (ESICM) joint guidelines for post-resuscitation care recommend a multimodal approach to prognostication of neurological outcome. However, head computed tomography (CT) which is commonly used for predicting long-term neurological outcome after cardiac arrest has not yet been examined prospectively in a clinical trial. The primary purpose of the TTM-2 CT-substudy is to prospectively investigate and compare various methods of diagnosing generalized oedema on CT after cardiac arrest and it´s ability to predict long-term neurological outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

November 18, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 5, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 12, 2023

Completed
Last Updated

March 22, 2024

Status Verified

March 1, 2024

Enrollment Period

5.1 years

First QC Date

April 5, 2019

Last Update Submit

March 20, 2024

Conditions

Heart Arrest, Out-Of-HospitalComputed TomographyUnconsciousnessNeurologic Deficits

Keywords

Cardiac arrestHypothermiaNeurological functionCardiovascular diseaseCerebral oedemaCerebral edemaCerebral ischaemiaCerebral ischemiaGray-white-matter differentiationGrey-white-matter differentiationROIRegions of interestCTGWRNeurological prognostication

Outcome Measures

Primary Outcomes (1)

  • Poor functional outcome

    Assessed using the modified Rankin Scale (mRS), with a score of 4-6 being a poor outcome.

    180 days

Secondary Outcomes (3)

  • Exploratory: Neurocognitive outcome

    180 days

  • Exploratory: Neurocognitive outcome

    180 days

  • Exploratory: Functional outcome

    180 days

Study Arms (1)

Included patients

Cardiac arrest patients from sites participating in the TTM-2 CT-substudy still unconscious 48 hours after cardiac arrest are routinely examined with head computed tomography as soon as possible after inclusion.

Diagnostic Test: CT

Interventions

CTDIAGNOSTIC_TEST

Head computed tomography on patients still unconscious 48 hours after cardiac arrest.Visual evaluation of generalized oedema ("eye-balling"). Manual and automated measurement of the differentiation of gray and white matter (GWR) using circular regions of interest (ROI).

Included patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult patients with Out-of hospital cardiac arrest included in the TTM-2 trial and randomized to either targeted temperature management at 33°C or early treatment of fever.

You may qualify if:

  • Out-of-hospital cardiac arrest
  • Presumed cardiac cause of cardiac arrest
  • Unconscious with a FOUR-score \<M4 (not obeying verbal commands)
  • Stable return of spontaneous circulation (20 min)
  • Eligible for intensive care treatment without restrictions
  • Patient from participating centers, where head CT is routinely performed on all patients still unconscious 48 hours after cardiac arrest

You may not qualify if:

  • Unwitnessed cardiac arrest with an initial rhythm of asystole
  • Temperature on admission \<30°C.
  • Obvious or suspected pregnancy
  • Intracranial bleeding
  • On ECMO prior to ROSC
  • Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy
  • Patients from centers not participating in the TTM-2 CT-substudy
  • Patients from participating centers not examined with head CT

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marion Moseby-Knappe

Lund, Skåne County, 22185, Sweden

Location

Related Publications (3)

  • Moseby-Knappe M, Pellis T, Dragancea I, Friberg H, Nielsen N, Horn J, Kuiper M, Roncarati A, Siemund R, Unden J, Cronberg T; TTM-trial investigators. Head computed tomography for prognostication of poor outcome in comatose patients after cardiac arrest and targeted temperature management. Resuscitation. 2017 Oct;119:89-94. doi: 10.1016/j.resuscitation.2017.06.027. Epub 2017 Jul 4.

    PMID: 28687281RESULT

  • Lang M, Kenda M, Scheel M, Martola J, Wheeler M, Owen S, Johnsson M, Annborn M, Dankiewicz J, Deye N, During J, Halliday T, Jakobsen JC, Lascarrou JB, Levin H, Lilja G, Lybeck A, McGuigan PJ, Rylander C, Sem V, Thomas M, Ullen S, Unden J, Wise MP, Cronberg T, Wasselius J, Nielsen N, Leithner C, Moseby-Knappe M. Radiological signs of hypoxic-ischaemic encephalopathy on head computed tomography for prediction of poor functional outcome after cardiac arrest - a prospective observational cohort study. Resuscitation. 2025 Sep;214:110675. doi: 10.1016/j.resuscitation.2025.110675. Epub 2025 Jun 9.

    PMID: 40499676DERIVED

  • Lang M, Leithner C, Scheel M, Kenda M, Cronberg T, During J, Rylander C, Annborn M, Dankiewicz J, Deye N, Halliday T, Lascarrou JB, Matthew T, McGuigan P, Morgan M, Thomas M, Ullen S, Unden J, Nielsen N, Moseby-Knappe M. Prognostic accuracy of head computed tomography for prediction of functional outcome after out-of-hospital cardiac arrest: Rationale and design of the prospective TTM2-CT-substudy. Resusc Plus. 2022 Oct 12;12:100316. doi: 10.1016/j.resplu.2022.100316. eCollection 2022 Dec.

    PMID: 36267356DERIVED

Related Links

Biospecimen

Retention: NONE RETAINED

Serum samples collected in the main trial TTM-2 (ClinicalTrials.gov Identifier: NCT02908308)

MeSH Terms

Conditions

Out-of-Hospital Cardiac ArrestUnconsciousnessNeurologic ManifestationsHeart ArrestHypothermiaCardiovascular DiseasesBrain EdemaCerebral InfarctionBrain Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesConsciousness DisordersNeurobehavioral ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsBody Temperature ChangesBrain DiseasesCentral Nervous System DiseasesBrain InfarctionCerebrovascular DisordersStrokeVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Marion Moseby-Knappe, MD

    Lund University and Skane University Hospitals Sweden

    PRINCIPAL INVESTIGATOR

  • Tobias Cronberg, MD, PhD

    Lund University and Skane University Hospitals Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2019

First Posted

April 12, 2019

Study Start

November 18, 2017

Primary Completion

December 31, 2022

Study Completion

March 12, 2023

Last Updated

March 22, 2024

Record last verified: 2024-03

Locations

SE(1)