Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation (TOMAHAWK)
Primary Purpose
Out-of-hospital Cardiac Arrest
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
Immediate coronary angiography
Delayed/selective coronary angiography
Sponsored by
About this trial
This is an interventional treatment trial for Out-of-hospital Cardiac Arrest
Eligibility Criteria
Inclusion Criteria:
- Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
- Age ≥30 years
- Informed consent
Exclusion Criteria:
- ST-segment elevation or new left bundle branch block
- No return of spontaneous circulation upon hospital admission
- Severe hemodynamic or electrical instability requiring immediate coronary angiography/intervention (delay clinically not acceptable)
- Obvious extra-cardiac etiology such as traumatic brain injury, primary metabolic or electrolyte disorders, intoxication, overt hemorrhage, respiratory failure due to known lung disease, suffocation, drowning
- In-hospital cardiac arrest
- Known or likely pregnancy
- Participation in another intervention study
Sites / Locations
- Universitäres Herzzentrum Lübeck
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Immediate coronary angiography
Delayed/selective coronary angiography
Arm Description
Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated
Outcomes
Primary Outcome Measures
All-cause mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT02750462
First Posted
April 20, 2016
Last Updated
October 1, 2019
Sponsor
University Hospital Schleswig-Holstein
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
1. Study Identification
Unique Protocol Identification Number
NCT02750462
Brief Title
Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
Acronym
TOMAHAWK
Official Title
Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
September 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Schleswig-Holstein
Collaborators
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of the trial is to compare immediate angiography in survivors of out of hospital cardiac arrest (OHCA) without ST-segment elevation versus delayed/selective catheterization with respect to 30 day mortality.
The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).
Detailed Description
After inclusion and exclusion criteria have been checked patients will be randomized:
Group 1: Immediate angiography Patients randomized to group 1 will be transported to the catheterization laboratory as soon as possible after hospital admission for evaluation of coronary anatomy.
Group 2: Delayed/selective angiography Upon hospital admission, patients assigned to group 2 will first be transported to the ICU for further evaluation and stratification of OHCA etiology. Further triage will depend on the results of clinical examination and objective testing and will be left to the individual physician according to clinical judgment. Depending on clinical circumstances, further management may comprise medical therapy, laboratory testing, imaging such as echocardiography and/or computed tomography, hemodynamic or neurological monitoring, the initiation of therapeutic hypothermia or other measures of intensive care. If a high likelihood of an acute coronary trigger for OHCA persists (i.e. inconclusive results from clinical evaluation with ongoing suspicion of an acute coronary event, etc.), the treating physician may proceed to coronary angiography after a delay of 24h after the onset of cardiac arrest.
Vital status will be assessed at 30 days, 6 and 12 months after randomization by direct questioning if the patient is still hospitalized or structured telephone interview. Clinical events will be verified by original source data. At 6 and 12 months, quality of life will be assessed by the the Euroqol 5D questionnaire.
The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-hospital Cardiac Arrest
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
558 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Immediate coronary angiography
Arm Type
Experimental
Arm Description
Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
Arm Title
Delayed/selective coronary angiography
Arm Type
Active Comparator
Arm Description
Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated
Intervention Type
Other
Intervention Name(s)
Immediate coronary angiography
Intervention Description
Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
Intervention Type
Other
Intervention Name(s)
Delayed/selective coronary angiography
Intervention Description
Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated
Primary Outcome Measure Information:
Title
All-cause mortality
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
Age ≥30 years
Informed consent
Exclusion Criteria:
ST-segment elevation or new left bundle branch block
No return of spontaneous circulation upon hospital admission
Severe hemodynamic or electrical instability requiring immediate coronary angiography/intervention (delay clinically not acceptable)
Obvious extra-cardiac etiology such as traumatic brain injury, primary metabolic or electrolyte disorders, intoxication, overt hemorrhage, respiratory failure due to known lung disease, suffocation, drowning
In-hospital cardiac arrest
Known or likely pregnancy
Participation in another intervention study
Facility Information:
Facility Name
Universitäres Herzzentrum Lübeck
City
Lübeck
State/Province
Schleswig-Holstein
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34459570
Citation
Desch S, Freund A, Akin I, Behnes M, Preusch MR, Zelniker TA, Skurk C, Landmesser U, Graf T, Eitel I, Fuernau G, Haake H, Nordbeck P, Hammer F, Felix SB, Hassager C, Engstrom T, Fichtlscherer S, Ledwoch J, Lenk K, Joner M, Steiner S, Liebetrau C, Voigt I, Zeymer U, Brand M, Schmitz R, Horstkotte J, Jacobshagen C, Poss J, Abdel-Wahab M, Lurz P, Jobs A, de Waha-Thiele S, Olbrich D, Sandig F, Konig IR, Brett S, Vens M, Klinge K, Thiele H; TOMAHAWK Investigators. Angiography after Out-of-Hospital Cardiac Arrest without ST-Segment Elevation. N Engl J Med. 2021 Dec 30;385(27):2544-2553. doi: 10.1056/NEJMoa2101909. Epub 2021 Aug 29.
Results Reference
derived
PubMed Identifier
30639610
Citation
Desch S, Freund A, Graf T, Fichtlscherer S, Haake H, Preusch M, Hammer F, Akin I, Christ M, Liebetrau C, Skurk C, Steiner S, Voigt I, Schmitz R, Mudra H, Ledwoch J, Menck N, Horstkotte J, Pels K, Lahmann AL, Otto S, Lenk K, Ohlow MA, Hassager C, Nordbeck P, Zeymer U, Jobs A, de Waha-Thiele S, Olbrich D, Konig I, Klinge K, Thiele H. Immediate unselected coronary angiography versus delayed triage in survivors of out-of-hospital cardiac arrest without ST-segment elevation: Design and rationale of the TOMAHAWK trial. Am Heart J. 2019 Mar;209:20-28. doi: 10.1016/j.ahj.2018.12.005. Epub 2018 Dec 11.
Results Reference
derived
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Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
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