Type of Access to the Blood Circulation During Cardiac Arrest Outside the Hospital

Intravenous vs. Intraosseous Vascular Access During Out-of-Hospital Cardiac Arrest - A Randomized Clinical Trial - IVIO

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005922-82-DK

Enrollment

762

Registered

2021-11-04

Start date

2022-01-13

Completion date

Unknown

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Out-of-hospital cardiac arrest (OHCA) MedDRA version: 20.0 Level: LLT Classification code 10007517 Term: Cardiac arrest transient System Organ Class: 100000004849

Interventions

Trade Name: Adrenalin "SAD" Product Name: Adrenaline tartrate Pharmaceutical Form: Solution for injection Trade Name: Cordarone (Amiodarone) Product Name: Amiodarone hydrochloride Pharmaceutical For

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) OHCA 2) Age = 18 years 3) Indication for intravenous or intraosseous vascular access during cardiac arrest Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 254 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 508

Exclusion criteria

Exclusion criteria: 1) Blunt or penetrating traumatic cardiac arrest 2) Prior enrollment in the trial 3) Intravenous or intraosseous vascular access already in place and working when the first trial-participating unit arrives on site

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether there is a difference in return of spontaneous circulation depending on the type of vascular access (intravenous or intraosseous) placed during out-of-hospital cardiac arrest;Secondary Objective: To determine whether there is a difference in survival at 30 days and/or survival at 30 days with a favorable neurological outcome (modified Rankin Scale, mRS 0-3) depending on the type of vascular access (intravenous or intraosseous) placed during out-of-hospital cardiac arrest;Primary end point(s): The primary endpoint is sustained return of spontaneous circulation (ROSC) ROSC is defined as palpable pulses or other signs of circulation without a need for chest compressions. Sustained ROSC means that the patient withholds ROSC >20 min;Timepoint(s) of evaluation of this end point: The endpoint is evaluated during ongoing cardiopulmonary resuscitation	—

Measure

Time frame

Main Objective: To determine whether there is a difference in return of spontaneous circulation depending on the type of vascular access (intravenous or intraosseous) placed during out-of-hospital cardiac arrest;Secondary Objective: To determine whether there is a difference in survival at 30 days and/or survival at 30 days with a favorable neurological outcome (modified Rankin Scale, mRS 0-3) depending on the type of vascular access (intravenous or intraosseous) placed during out-of-hospital cardiac arrest;Primary end point(s): The primary endpoint is sustained return of spontaneous circulation (ROSC) ROSC is defined as palpable pulses or other signs of circulation without a need for chest compressions. Sustained ROSC means that the patient withholds ROSC >20 min;Timepoint(s) of evaluation of this end point: The endpoint is evaluated during ongoing cardiopulmonary resuscitation

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Secondary

Measure	Time frame
Secondary end point(s): Key secondary outcomes will include survival as well as neurological outcome at 30 days. Neurological outcome will be assessed with the modified Rankin Scale (mRS); scores 0-6 will be presented as counts and percentages, while the outcome will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).;Timepoint(s) of evaluation of this end point: 30 days after the cardiac arrest	—

Measure

Time frame

Secondary end point(s): Key secondary outcomes will include survival as well as neurological outcome at 30 days. Neurological outcome will be assessed with the modified Rankin Scale (mRS); scores 0-6 will be presented as counts and percentages, while the outcome will be dichotomized as favorable (mRS 0-3) vs. unfavorable (mRS 4-6).;Timepoint(s) of evaluation of this end point: 30 days after the cardiac arrest

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Countries

Denmark

Contacts

Public ContactResearch and Development

Prehospital Emergency Medical Services, Central Denmark Region

lwandersen@clin.au.dk004578414912

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026