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| Name | Class |
|---|---|
| Central Denmark Region | OTHER |
| University of Aarhus | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intraosseous access | Device | Needle placed in the bone marrow. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained return of spontaneous circulation | Palpable pulses or other signs of circulation without a need for chest compressions lasting at least 20 minutes | Before or after hospital arrival (up to 2 hours after the cardiac arrest) |
| Measure | Description | Time Frame |
|---|---|---|
| Survival | 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emergency Medical Services, the North Denmark Region | Aalborg | 9000 | Denmark | |||
| Prehospital Emergency Medical Services, Central Denmark Region |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41967754 | Derived | 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. | |
| 40348355 |
| Label | URL |
|---|---|
| Trial website | View source |
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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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| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Intravenous |
| Device |
Needle placed in a vein. |
|
| 30 days after the cardiac arrest |
| Aarhus N |
| 8200 |
| Denmark |
| Copenhagen Emergency Medical Services, the Capital Region of Denmark | Ballerup Municipality | 2750 | Denmark |
| The Prehospital Center, Region Zealand | Næstved | 4700 | Denmark |
| Emergency Medical Services, the Region of Southern Denmark | Vejle | 7100 | Denmark |
| Derived |
| 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, 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. |
| 39480221 | Derived | Vallentin 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. |