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

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

Tracking Information

• First Submitted Date: April 20, 2016
• First Posted Date: April 25, 2016
• Last Update Posted Date: October 4, 2019
• Actual Study Start Date: November 2016
• Actual Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: April 20, 2016): All-cause mortality [ Time Frame: 30 days ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Out-of-hospital Cardiac Arrest

Intervention

• 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

• 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 *: 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, König 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 20, 2016): 558
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: September 2019
• Actual Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 30 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT02750462
• Other Study ID Numbers: TOMAHAWK2.0
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Steffen Desch, University Hospital Schleswig-Holstein
• Study Sponsor: University Hospital Schleswig-Holstein
• Collaborators: Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
• Investigators: Not Provided
• PRS Account: University Hospital Schleswig-Holstein
• Verification Date: October 2019