Out-of-hospital Cardiac ArrestPhase 4TOMAHAWKNCT02750462
Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
A Phase 4 study testing Immediate coronary angiography and Delayed/selective coronary angiography in people with Out-of-hospital Cardiac Arrest, run by University Hospital Schleswig-Holstein at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Out-of-hospital Cardiac Arrest
- What is being tested?
- Immediate coronary angiography and Delayed/selective coronary angiography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 558 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2016to Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
- Age ≥30 years
- Informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitäres Herzzentrum Lübeck
Lübeck, Schleswig-Holstein, 23538
About this study
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).
Read the 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).
- Conditions
- Out-of-hospital Cardiac Arrest
- Being tested
- Immediate coronary angiography, Delayed/selective coronary angiography
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate coronary angiographyOther
Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
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
| Study group | Role | What they receive |
|---|---|---|
| Immediate coronary angiography | Experimental | Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation Receives: 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 Receives: Other: Delayed/selective coronary angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study startNov 2016
- Primary completionSep 2019
- Study completionSep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Out-of-hospital Cardiac ArrestStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 558 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Schleswig-Holstein
- Sponsor type
- University, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Responsible party
- Principal investigator, Steffen Desch, University Hospital Schleswig-Holstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750462
- Sponsor's protocol ID
- TOMAHAWK2.0
- Acronym
- TOMAHAWK
- Status last verified
- Oct 2019
- First submitted
- 20 Apr 2016
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 40557995Spoormans 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.
PubMed 40434768Desch 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.
PubMed 37556123Desch 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.
PubMed 34459570Desch 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.
PubMed 30639610
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation
- ClinicalTrials.gov ID
- NCT02750462
- Acronym / sponsor ID
- TOMAHAWK / TOMAHAWK2.0
- Conditions
- Out-of-hospital Cardiac Arrest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 558 participants (actual)
- Lead sponsor
- University Hospital Schleswig-HolsteinUniversity, hospital or other
- Collaborators
- Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)
- Study start
- Nov 2016 (actual)
- Primary completion
- Sep 2019 (actual)
- Study completion
- Sep 2019 (actual)
- First posted
- 25 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate coronary angiography | Experimental | Other: Immediate coronary angiographyImmediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation |
| Delayed/selective coronary angiography | Active comparator | Other: Delayed/selective coronary angiographyInitial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
- Age ≥30 years
- Informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate coronary angiographyImmediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation | Other | Immediate coronary angiography |
| Delayed/selective coronary angiographyInitial 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 |
Primary outcome
All-cause mortality
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2019.
- Derived from this study: PubMed 40557995Rossberg 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.
- Derived from this study: PubMed 40434768Spoormans 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.
- Derived from this study: PubMed 37556123Desch 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.
- Derived from this study: PubMed 34459570Desch 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.
- Derived from this study: PubMed 30639610Desch 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Immediate coronary angiography and Delayed/selective coronary angiography in people with Out-of-hospital Cardiac Arrest, run by University Hospital Schleswig-Holstein at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02750462, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.