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Trial record 1 of 1 for:    NCT02750462
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Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation (TOMAHAWK)

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ClinicalTrials.gov Identifier: NCT02750462
Recruitment Status : Completed
First Posted : April 25, 2016
Last Update Posted : October 4, 2019
Sponsor:
Collaborator:
Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Information provided by (Responsible Party):
Steffen Desch, University of Schleswig-Holstein

Tracking Information
First Submitted Date  ICMJE April 20, 2016
First Posted Date  ICMJE April 25, 2016
Last Update Posted Date October 4, 2019
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 20, 2016)
All-cause mortality [ Time Frame: 30 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02750462 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
Official Title  ICMJE Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Out-of-hospital Cardiac Arrest
Intervention  ICMJE
  • Other: Immediate coronary angiography
    Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
  • Other: Delayed/selective coronary angiography
    Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated
Study Arms  ICMJE
  • Experimental: Immediate coronary angiography
    Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
    Intervention: Other: Immediate coronary angiography
  • Active Comparator: Delayed/selective coronary angiography
    Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated
    Intervention: Other: Delayed/selective coronary angiography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2016)
558
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2019
Actual Primary Completion Date September 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02750462
Other Study ID Numbers  ICMJE TOMAHAWK2.0
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steffen Desch, University of Schleswig-Holstein
Study Sponsor  ICMJE University of Schleswig-Holstein
Collaborators  ICMJE Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
Investigators  ICMJE Not Provided
PRS Account University of Schleswig-Holstein
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP