Cardiac ArrestPhase 4IVIONCT05205031
Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital
A Phase 4 study testing Intraosseous access and Intravenous in people with Cardiac Arrest, run by Lars Wiuff Andersen at 5 sites in Denmark.
Trial summary
The "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Intraosseous access and Intravenous
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,479 participants
- Where
- 5 sitesDenmark
- Study dates
- 1 Mar 2022to 5 May 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out-of-hospital cardiac arrest
- Age ≥ 18 years
- Indication for intravenous or intraosseous vascular access during cardiac arrest
Who cannot join
- Blunt or penetrating traumatic cardiac arrest
- Prior enrollment in the trial
- Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Denmark5 sites
Emergency Medical Services, the North Denmark Region
Aalborg, 9000
Prehospital Emergency Medical Services, Central Denmark Region
Aarhus N, 8200
Copenhagen Emergency Medical Services, the Capital Region of Denmark
Ballerup Municipality, 2750
The Prehospital Center, Region Zealand
Næstved, 4700
Emergency Medical Services, the Region of Southern Denmark
Vejle, 7100
About this study
Official title: Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial
The "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. The intraosseous group will be further randomized to humeral vs. tibial access. The trial will be conducted in the Central Denmark Region. The primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. Key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
- Conditions
- Cardiac Arrest
- Being tested
- Intraosseous access, Intravenous
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraosseous accessDevice
Needle placed in the bone marrow.
IntravenousDevice
Needle placed in a vein.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous | Active comparator | The intervention will consist of attempts to successfully establish a peripheral intravenous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times. Receives: Device: Intravenous |
| Intraosseous | Experimental | The intervention will consist of attempts to successfully establish an intraosseous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times. Receives: Device: Intraosseous access |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained return of spontaneous circulation
Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes
Measured: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Secondary outcomes (2)
Survival
Measured: 30 days after the cardiac arrest
Favorable neurological outcome
Neurological outcome will be assessed with the modified Rankin Scale (mRS) which is a scale from 0 to 6 assessing neurological/functional outcomes after brain damage with higher scores indicating worse neurological/functional outcomes. The scale will will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).
Measured: 30 days after the cardiac arrest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start1 Mar 2022
- Primary completion5 May 2024
- Study completion5 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 1,479 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lars Wiuff Andersen
- Sponsor type
- University, hospital or other
- Collaborators
- Central Denmark Region, University of Aarhus
- Responsible party
- Sponsor-investigator, Lars Wiuff Andersen, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205031
- Sponsor's protocol ID
- 00003
- Acronym
- IVIO
- Status last verified
- Sep 2024
- First submitted
- 11 Jan 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.
Publications
Vallentin MF, Holmberg MJ, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Rasmussen LK, Mortensen LR, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Duus Holle SL, Russell L, Alstrom H, Hestad S, Hove Buciek JU, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Effect of vascular access strategy on long-term outcomes in patients with out-of-hospital cardiac arrest: a randomised clinical trial. Resuscitation. 2026 Jun;223:111087. doi: 10.1016/j.resuscitation.2026.111087. Epub 2026 Apr 10.
PubMed 41967754Vallentin MF, Holmberg MJ, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Rasmussen LK, Mortensen LR, Loldrup ML, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Holle SLD, Russell L, Alstrom H, Hestad S, Fogtmann TH, Hove Buciek JU, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Intraosseous vs. intravenous access during out-of-hospital cardiac arrest: a Bayesian secondary analysis of a randomised clinical trial. Resuscitation. 2025 Jul;212:110634. doi: 10.1016/j.resuscitation.2025.110634. Epub 2025 May 17.
PubMed 40348355Vallentin MF, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Holmberg MJ, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard Rasmussen L, Mortensen LR, Loldrup ML, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Holle SLD, Russell L, Alstrom H, Hestad S, Fogtmann TH, Buciek JUH, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Intraosseous or Intravenous Vascular Access for Out-of-Hospital Cardiac Arrest. N Engl J Med. 2025 Jan 23;392(4):349-360. doi: 10.1056/NEJMoa2407616. Epub 2024 Oct 31.
PubMed 39480221
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05205031
- Acronym / sponsor ID
- IVIO / 00003
- Conditions
- Cardiac Arrest
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,479 participants (actual)
- Lead sponsor
- Lars Wiuff AndersenUniversity, hospital or other
- Collaborators
- Central Denmark Region, University of Aarhus
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 5 May 2024 (actual)
- Study completion
- 5 May 2025 (estimated)
- First posted
- 24 Jan 2022 (actual)
- 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 "Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest (IVIO)"-trial is an investigator-initiated, randomized, parallel group, patient and outcome assessor-blinded, superiority trial of intravenous vs. intraosseous vascular access during adult out-of-hospital cardiac arrest. The intraosseous group will be further randomized to humeral vs. tibial access. The trial will be conducted in the Central Denmark Region. The primary outcome will be sustained return of spontaneous circulation, and 762 patients will be included. Key secondary outcomes include survival at 30 days and survival at 30 days with a favorable neurological outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous | Active comparator | Device: IntravenousThe intervention will consist of attempts to successfully establish a peripheral intravenous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times. |
| Intraosseous | Experimental | Device: Intraosseous accessThe intervention will consist of attempts to successfully establish an intraosseous access during the cardiac arrest. The prehospital clinician will be required to attempt the intervention a minimum of two times. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Out-of-hospital cardiac arrest
- Age ≥ 18 years
- Indication for intravenous or intraosseous vascular access during cardiac arrest
Key exclusion criteria (3 listed)
- Blunt or penetrating traumatic cardiac arrest
- Prior enrollment in the trial
- Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site
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 |
|---|---|---|
| Intraosseous accessNeedle placed in the bone marrow. | Device | Intraosseous |
| IntravenousNeedle placed in a vein. | Device | Intravenous |
Primary outcome
Sustained return of spontaneous circulation
Time frame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)
Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes
2 secondary outcomes
Survival
Time frame: 30 days after the cardiac arrest
Favorable neurological outcome
Time frame: 30 days after the cardiac arrest
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Derived from this study: PubMed 41967754Vallentin MF, Holmberg MJ, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Rasmussen LK, Mortensen LR, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Duus Holle SL, Russell L, Alstrom H, Hestad S, Hove Buciek JU, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Effect of vascular access strategy on long-term outcomes in patients with out-of-hospital cardiac arrest: a randomised clinical trial. Resuscitation. 2026 Jun;223:111087. doi: 10.1016/j.resuscitation.2026.111087. Epub 2026 Apr 10.
- Derived from this study: PubMed 40348355Vallentin MF, Holmberg MJ, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Rasmussen LK, Mortensen LR, Loldrup ML, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Holle SLD, Russell L, Alstrom H, Hestad S, Fogtmann TH, Hove Buciek JU, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Intraosseous vs. intravenous access during out-of-hospital cardiac arrest: a Bayesian secondary analysis of a randomised clinical trial. Resuscitation. 2025 Jul;212:110634. doi: 10.1016/j.resuscitation.2025.110634. Epub 2025 May 17.
- Derived from this study: PubMed 39480221Vallentin MF, Granfeldt A, Klitgaard TL, Mikkelsen S, Folke F, Christensen HC, Povlsen AL, Petersen AH, Winther S, Frilund LW, Meilandt C, Holmberg MJ, Winther KB, Bach A, Dissing TH, Terkelsen CJ, Christensen S, Kirkegaard Rasmussen L, Mortensen LR, Loldrup ML, Elkmann T, Nielsen AG, Runge C, Klaestrup E, Holm JH, Bak M, Nielsen LR, Pedersen M, Kjaergaard-Andersen G, Hansen PM, Brochner AC, Christensen EF, Nielsen FM, Nissen CG, Bjorn JW, Burholt P, Obling LER, Holle SLD, Russell L, Alstrom H, Hestad S, Fogtmann TH, Buciek JUH, Jakobsen K, Krag M, Sandgaard M, Sindberg B, Andersen LW. Intraosseous or Intravenous Vascular Access for Out-of-Hospital Cardiac Arrest. N Engl J Med. 2025 Jan 23;392(4):349-360. doi: 10.1056/NEJMoa2407616. Epub 2024 Oct 31.
- Trial websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Six months after the publication of the last results, all de-identified individual patient data will be made available for data sharing.
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intraosseous access and Intravenous in people with Cardiac Arrest, run by Lars Wiuff Andersen at 5 sites in Denmark.
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 3 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Denmark. 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?
Results are not available in the source record.
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?
Sustained return of spontaneous circulation (time frame: Before or after hospital arrival (up to 2 hours after the cardiac arrest)). 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 NCT05205031, which also lists 3 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 19 Sep 2024.