NCT02750462

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
558

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 25, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2019

Completed
Last Updated

October 4, 2019

Status Verified

October 1, 2019

Enrollment Period

2.8 years

First QC Date

April 20, 2016

Last Update Submit

October 1, 2019

Conditions

Out-of-hospital Cardiac Arrest

Outcome Measures

Primary Outcomes (1)

  • All-cause mortality

    30 days

Study Arms (2)

Immediate coronary angiography

EXPERIMENTAL

Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation

Other: Immediate coronary angiography

Delayed/selective coronary angiography

ACTIVE COMPARATOR

Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated

Other: Delayed/selective coronary angiography

Interventions

Immediate coronary angiographyOTHER

Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation

Immediate coronary angiography
Delayed/selective coronary angiographyOTHER

Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated

Delayed/selective coronary angiography

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
  • Age ≥30 years
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitäres Herzzentrum Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

Location

Related Publications (5)

  • Rossberg M, Freund A, Thevathasan T, Skurk C, Koenig IR, Vens M, Grube H, Sandig F, Klinge K, Akin I, Fuernau G, Hassager C, Zeymer U, Preusch MR, Graf T, Jobs A, de Waha S, Thiele H, Poess J, Desch S. Quality of life after out-of-hospital cardiac arrest: a TOMAHAWK sub-study. Eur Heart J Acute Cardiovasc Care. 2025 Oct 7;14(9):511-519. doi: 10.1093/ehjacc/zuaf093.

    PMID: 40557995DERIVED

  • Spoormans EM, Thevathasan T, van Royen N, Zwinderman AH, Freund A, Thiele H, Ziesemer K, Desch S, Lemkes JS; COACT and TOMAHAWK Trials Investigators. One-Year Outcomes of Coronary Angiography After Out-of-Hospital Cardiac Arrest Without ST Elevation: An Individual Patient Data Meta-Analysis. JAMA Cardiol. 2025 Aug 1;10(8):779-786. doi: 10.1001/jamacardio.2025.1194.

    PMID: 40434768DERIVED

  • 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, Kjaergaard J, 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 S, Olbrich D, Sandig F, Konig IR, Brett S, Vens M, Klinge K, Thiele H; TOMAHAWK Investigators. Coronary Angiography After Out-of-Hospital Cardiac Arrest Without ST-Segment Elevation: One-Year Outcomes of a Randomized Clinical Trial. JAMA Cardiol. 2023 Sep 1;8(9):827-834. doi: 10.1001/jamacardio.2023.2264.

    PMID: 37556123DERIVED

  • 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.

    PMID: 34459570DERIVED

  • 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.

    PMID: 30639610DERIVED

MeSH Terms

Conditions

Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate director

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 25, 2016

Study Start

November 1, 2016

Primary Completion

September 1, 2019

Study Completion

September 1, 2019

Last Updated

October 4, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)