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Cognitive Impairment Following Cardiac Arrest and Target Temperature Management

R

Region Skane

Status

Completed

Conditions

Cognition Disorders
Heart Arrest
Brain Injury
Out-of-hospital Cardiac Arrest

Treatments

Other: Temperature treatment

Study type

Interventional

Funder types

Other

Identifiers

NCT01946932
TTMcogsub

Details and patient eligibility

About

This is a steering group approved substudy to the Target Temperature Management trial (TTM, ClinicalTrials.gov Identifier: NCT01020916). TTM compares the effect of two strictly controlled temperature regimes for survivors of out-of-hospital cardiac arrest.

The primary aim of this sub-study is to compare the amount of cognitive impairment in cardiac arrest survivors treated with 33 degrees and 36 degrees and with a matched group of control patients with myocardial infarction.

Our secondary aims are:

  • To investigate the impact of cognitive impairment on our patients' ability to participate in society and their health related quality of life.
  • To investigate the relationship between our patients cognitive impairments and their relatives/informants health related quality of life and feelings of burden.
  • To test the hypothesis that the simple cognitive screening battery used in the TTM main trial is sensitive enough to detect all patients with significant cognitive disability.

Enrollment

287 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Age 18 years or older
  • Out-of-Hospital Cardiac Arrest (OHCA)of presumed cardiac cause
  • Unconsciousness after sustained return of spontaneous circulation (ROSC)

Exclusion Criteria at time for inclusion in the TTM study:

  • Known bleeding diathesis

  • Suspected or confirmed acute intracranial bleeding

  • Suspected or confirmed stroke

  • Unwitnessed asystole

  • Known limitations in therapy and Do Not Resuscitate-order

  • Known disease making 180 days survival unlikely

  • Known prearrest status Cerebral Performance Category (CPC)3 or 4

  • Temperature <30°on admission

    • 4 hours (240 minutes) from ROSC to screening
  • Systolic blood pressure <80 mm Hg in spite of fluid loading/vasopressor and/or inotropic medication/intra aortic balloon pump

  • In-hospital cardiac arrest

  • OHCA of presumed non-cardiac arrest cause

Additional Exclusion criteria for the sub-study:

  • Disability to speak the site language well enough to complete tests without interpreter
  • Controls should never have suffered a cardiac arrest

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

287 participants in 2 patient groups

Cardiac Arrest 33°
Active Comparator group
Description:
survivors with temperature treatment 33°
Treatment:
Other: Temperature treatment
Cardiac Arrest survivors 36°
Active Comparator group
Description:
survivors with temperature treatment 36°
Treatment:
Other: Temperature treatment

Trial contacts and locations

20

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Data sourced from clinicaltrials.gov

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