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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02908308




Registration number
NCT02908308
Ethics application status
Date submitted
16/09/2016
Date registered
20/09/2016

Titles & IDs
Public title
Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest
Scientific title
Targeted Hypothermia Versus Targeted Normothermia After Out-of-hospital Cardiac Arrest (TTM2) - A Randomised Clinical Trial
Secondary ID [1] 0 0
TTM-2
Universal Trial Number (UTN)
Trial acronym
TTM-2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Out-of-hospital Cardiac Arrest 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Surgery - Targeted temperature management to 33°C
Treatment: Surgery - Standard care with early treatment of fever

Active comparator: Normothermia - Standard care with early treatment of fever. Active temperature control with a device will be used if the patient develops a temperature greater than or equal 37.8°C.

Experimental: Hypothermia - Targeted temperature management to 33°C for up to 28h.


Treatment: Surgery: Targeted temperature management to 33°C
Rapid cooling to below 33°C, followed by temperature control at 33°C for up to 28h.

Treatment: Surgery: Standard care with early treatment of fever
Normothermia and standard care - use of a device for temperature control if temperature is greater than or equal to 37.8°C
Intervention code [1] 0 0
Treatment: Surgery
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mortality
Timepoint [1] 0 0
180 days
Secondary outcome [1] 0 0
Poor functional outcome
Timepoint [1] 0 0
180 days
Secondary outcome [2] 0 0
Days alive outside hospital
Timepoint [2] 0 0
180 days.
Secondary outcome [3] 0 0
Quality of Life
Timepoint [3] 0 0
180 days
Secondary outcome [4] 0 0
Quality of Life
Timepoint [4] 0 0
180 days
Secondary outcome [5] 0 0
Survival until end of the trial
Timepoint [5] 0 0
180 days after randmomization of the last patient

Eligibility
Key inclusion criteria
* 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
* Inclusion within 180 minutes of ROSC
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Unwitnessed cardiac arrest with an initial rhythm of asystole
* Temperature on admission <30°C.
* On ECMO prior to ROSC
* Obvious or suspected pregnancy
* Intracranial bleeding
* On ECMO prior to ROSC
* Severe chronic obstructive pulmonary disorder (COPD) with long-term home oxygen therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/11/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/12/2022
Sample size
Target
Accrual to date
Final
1900
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
John Hunter Hospital - Newcastle
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Sydney
Recruitment hospital [3] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [4] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [5] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [6] 0 0
Northern Hospital - Epping
Recruitment hospital [7] 0 0
The Alfred - Melbourne
Recruitment hospital [8] 0 0
Austin Hospital - Melbourne
Recruitment hospital [9] 0 0
Nepean Hospital - Sydney
Recruitment hospital [10] 0 0
Royal North Shore Hospital - Sydney
Recruitment postcode(s) [1] 0 0
- Newcastle
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment postcode(s) [3] 0 0
- Brisbane
Recruitment postcode(s) [4] 0 0
- Epping
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
New York
Country [2] 0 0
United States of America
State/province [2] 0 0
Pennsylvania
Country [3] 0 0
Austria
State/province [3] 0 0
Innsbruck
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
Belgium
State/province [5] 0 0
Genk
Country [6] 0 0
Czechia
State/province [6] 0 0
Hradec Králové
Country [7] 0 0
Czechia
State/province [7] 0 0
Liberec
Country [8] 0 0
Czechia
State/province [8] 0 0
Prague
Country [9] 0 0
Denmark
State/province [9] 0 0
Aarhus
Country [10] 0 0
France
State/province [10] 0 0
Limoges
Country [11] 0 0
France
State/province [11] 0 0
Nantes
Country [12] 0 0
France
State/province [12] 0 0
Paris
Country [13] 0 0
France
State/province [13] 0 0
Versailles
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Italy
State/province [15] 0 0
Genova
Country [16] 0 0
Italy
State/province [16] 0 0
Modena
Country [17] 0 0
New Zealand
State/province [17] 0 0
Christchurch
Country [18] 0 0
New Zealand
State/province [18] 0 0
Wellington
Country [19] 0 0
Norway
State/province [19] 0 0
Arendal
Country [20] 0 0
Norway
State/province [20] 0 0
Bergen
Country [21] 0 0
Norway
State/province [21] 0 0
Oslo
Country [22] 0 0
Norway
State/province [22] 0 0
Trondheim
Country [23] 0 0
Sweden
State/province [23] 0 0
Halland
Country [24] 0 0
Sweden
State/province [24] 0 0
Skåne
Country [25] 0 0
Sweden
State/province [25] 0 0
Gothenburg
Country [26] 0 0
Sweden
State/province [26] 0 0
Helsingborg
Country [27] 0 0
Sweden
State/province [27] 0 0
Karlstad
Country [28] 0 0
Sweden
State/province [28] 0 0
Linköping
Country [29] 0 0
Sweden
State/province [29] 0 0
Skövde
Country [30] 0 0
Sweden
State/province [30] 0 0
Stockholm
Country [31] 0 0
Sweden
State/province [31] 0 0
Trollhättan
Country [32] 0 0
Sweden
State/province [32] 0 0
Uppsala
Country [33] 0 0
Sweden
State/province [33] 0 0
Örebro
Country [34] 0 0
Switzerland
State/province [34] 0 0
Bern
Country [35] 0 0
Switzerland
State/province [35] 0 0
Lausanne
Country [36] 0 0
Switzerland
State/province [36] 0 0
Lugano
Country [37] 0 0
Switzerland
State/province [37] 0 0
Saint Gallen
Country [38] 0 0
Switzerland
State/province [38] 0 0
Zürich
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Basildon
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Belfast
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Birmingham
Country [42] 0 0
United Kingdom
State/province [42] 0 0
Bournemouth
Country [43] 0 0
United Kingdom
State/province [43] 0 0
Bristol
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Cardiff
Country [45] 0 0
United Kingdom
State/province [45] 0 0
Manchester
Country [46] 0 0
United Kingdom
State/province [46] 0 0
Portsmouth
Country [47] 0 0
United Kingdom
State/province [47] 0 0
Reading

Funding & Sponsors
Primary sponsor type
Other
Name
Helsingborgs Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Lund University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Region Skåne - Skånevård SUND
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Copenhagen Trial Unit, Center for Clinical Intervention Research
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Clinical Trials Sweden, Forum South
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Integrated Biobank of Luxembourg
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Niklas Nielsen, MD, PhD
Address 0 0
Helsingborgs lasarett, Region Skåne, Sweden
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02908308