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Clinical Trials/NCT02750462
NCT02750462
Completed
Phase 4

Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation

University Hospital Schleswig-Holstein1 site in 1 country558 target enrollmentNovember 2016

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Out-of-hospital Cardiac Arrest
Sponsor
University Hospital Schleswig-Holstein
Enrollment
558
Locations
1
Primary Endpoint
All-cause mortality
Status
Completed
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
November 2016
End Date
September 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Schleswig-Holstein
Responsible Party
Principal Investigator
Principal Investigator

Steffen Desch

Associate director

University Hospital Schleswig-Holstein

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

Outcomes

Primary Outcomes

All-cause mortality

Time Frame: 30 days

Study Sites (1)

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