The TTM2 Study

The TTM2 trial is a phase III, multi-centre, randomized, parallel-group, clinical trial in resuscitated cardiac arrest patients admitted to the intensive care unit to investigate whether targeted temperature management (TTM) to 33°C improves survival and neurological outcome at 6 months compared to a strategy of targeting normothermia and avoiding fever above 37.7°C.

The TTM2 Study

Background

  • For patients admitted to the ICU after a cardiac arrest, neurological injury leading to the withdrawal of life support or neurological impairment are the most common outcomes following cardiac arrest.
  • In studies using detailed instruments, cognitive impairment is reported to be present in 50% of survivors of cardiac arrest discharged from the hospital; this is associated with lower quality of life and increased caregiver strain.
  • Many interventions have been tested in order to lower mortality and improve neurologic function in patients resuscitated after out-of-hospital cardiac arrest. Despite promising results in experimental models, all but one have failed in clinical trials. To date, induced hypothermia is the only intervention that has shown promising results in preliminary clinical trials.

Facts

  • An out-of-hospital cardiac arrest has an estimated incidence of approximately 1 per 1,000 persons per year (approximately 25,000 individuals in Australia each year).
  • Australian mortality rates for heart attack range between 87-94%.
  • For each resuscitated cardiac arrest patient admitted to ICU who survives to hospital discharge, admission costs alone exceed $120,000. Moreover, the estimated ongoing community-based costs for each patient with moderate cerebral injury is AUD$34,000/year.

Aims

  • The TTM2 study aims to assess the beneficial and harmful effects of post-ischaemic hypothermia (33°C) when compared with normothermia and early treatment of fever (37.8°C) in unconscious adults after out-of-hospital cardiac arrest.

Methods

  • A 1900 patient, an international, multi-centre, parallel-group, phase III, non-commercial, randomised, controlled trial (RCT).
  • Participants with out-of-hospital cardiac arrest will be randomised to targeted temperature management with hypothermia at 33°C, or normothermia and early treatment of fever equal to or greater than 37.8°C.

Sponsor: Region Skåne – Skånevård SUND – Helsingborgs Hospital, S Vallgatan 5, 251 87 Helsingborg, Sweden

Coordinating centre:  Lund University Hospital, Lund, Sweden

Principal Investigator: Niklas Nielsen, MD, PhD, DEAA, EDIC, Department of Anaesthesiology and Intensive Care Helsingborg Hospital, Lund University, Faculty of Medicine, Sweden

Contacts: Josef Dankiewicz, MD, PhD +46734089480 ttm2@ttm2trial.org
Tobias Cronberg, MD, PhD +4646171000 tobias.cronberg@med.lu.se

Twitter: Follow news and updates from the TAME trial page on Twitter – https://twitter.com/TTM2trial

Software: Spinnaker, Spiral Software

Download the TTM2 Fact Sheet (.pdf)

For more details, visit the TTM2 trial information website: http://ttm2trial.org/

Twitter

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#TTM2trial

Study Database

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Study Database

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Study Database

Trial Registry

View this trial on the U.S. National Institutes of Health Clinical Trial Registry

Trial Registry

View this trial on the U.S. National Institutes of Health Clinical Trial Registry.
NCT02908308