Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ended
Participants planned
1,470
Countries
1
Sites
5
Out-of-hospital cardiac arrest (OHCA)
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
Key facts
- Sponsor
- Præhospitalet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 1 Mar 2022 → 5 May 2025
- Decision date (initial)
- 2022-07-04
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- TrygFonden · Aarhus University · Snedkermester Sophus Jacobsen og hustru Astrid Jacobsens Fond through The Danish Heart Foundation · the Independent Research Fund Denmark · Novo Nordisk Foundation
External identifiers
- EU CT number
- 2022-500744-38-00
- EudraCT number
- 2021-005922-82
- ClinicalTrials.gov
- NCT05205031
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
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 objectives 1
- 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
Conditions and MedDRA coding
Out-of-hospital cardiac arrest (OHCA)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10007517 | Cardiac arrest transient | 10007541 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Out-of-hospital cardiac arrest
- Age ≥ 18 years
- Indication for intravenous or intraosseous vascular access during cardiac arrest
Exclusion criteria 3
- Blunt trauma, penetrating trauma, or burn injuries as suspected cause of the cardiac arrest
- Prior enrollment in the trial
- Intravenous or intraosseous vascular access already in place and working at the time of randomization
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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
Secondary endpoints 1
- 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).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SCP16873011 · ATC
- Active substance
- Adrenaline Tartrate Ph. Eur.
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 15 mg milligram(s)
- Max total dose
- 15 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA24 — EPINEPHRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
—
SCP177718 · ATC
- Route of administration
- INTRAVENOUS BOLUS USE
- Max daily dose
- 450 mg milligram(s)
- Max total dose
- 450 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01BD01 — AMIODARONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Præhospitalet
- Sponsor organisation
- Præhospitalet
- Address
- Olof Palmes Allé 34
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Præhospitalet
- Contact name
- Research and Development
Public contact point
- Organisation
- Præhospitalet
- Contact name
- Research and Development
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| GCP-enheden ved Københavns Universitetshospital ORL-000002325
|
Frederiksberg, Denmark | On site monitoring |
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 1,470 | 5 |
| Rest of world | — | 0 | — |
Investigational sites
Den Praehospitale Virksomhed
Department of Anesthesia and Intensive Care, Aalborg Unviersity Hospital, Hjulmagervej 20, 9000, Aalborg
Praehospital indsats Region Syddanmark
Præhospital Indsats, Region Syddanmark, Damhaven 12, 7100, Vejle
Præhospitalet
Research and Development, Præhospitalet Region Midt, Olof Palmes Allé 34, 8200, Aarhus N
Region Hovedstadens Akutberedskab
Forskning, Telegrafvej 5, opgang 2, Ballerup
Præhospitalt Center, Region Sjælland
Forskning, Ringstedgade 61, 13. etage, Næstved
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2022-03-01 | 2025-05-05 | 2022-03-02 | 2024-05-13 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Summary of results SUM-131146
|
2026-04-28T10:37:43 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Lay person summary of results | 2026-04-28T10:38:05 | Submitted | Laypersons Summary of Results |
Documents 2 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Lay Person Summary of Results | 1 |
| Summary of results (for publication) | Summary of Results | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-05-08 | Denmark | Acceptable 2022-05-24
|
2022-07-04 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-10-10 | Denmark | Acceptable 2022-12-12
|
2023-01-22 |
| 3 | SUBSTANTIAL MODIFICATION | SM-7 | 2023-08-14 | Denmark | Acceptable 2023-09-18
|
2023-09-29 |
| 4 | SUBSTANTIAL MODIFICATION | SM-8 | 2023-10-03 | Denmark | Acceptable | 2023-11-20 |