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

Phase 1

• Conditions: Out-of-hospital cardiac arrest (OHCA); MedDRA version: 20.0Level: LLTClassification code 10007517Term: Cardiac arrest transientSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005922-82-DK
• Lead Sponsor: Prehospital Emergency Medical Services, Central Denmark Region

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-04
• Last Update Posted: 26 February 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 762

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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)<br>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

Secondary Outcome Measures

Name	Time	Method
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