Overview
Sponsor-declared trial summary
Cardiac arrest
The primary objective of the study is to determine whether the use of a combination of adrenaline, vasopressin and steroids will increase 30 days survival in cardiac arrest patients compared to standard adrenaline alone
Key facts
- Sponsor
- Tiohundra AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Cardiovascular Diseases [C14]
- Trial duration
- 19 Dec 2022 → ongoing
- Decision date (initial)
- 2022-03-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2022-500137-89-00
- ClinicalTrials.gov
- NCT05139849
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy
The primary objective of the study is to determine whether the use of a combination of adrenaline, vasopressin and steroids will increase 30 days survival in cardiac arrest patients compared to standard adrenaline alone
Secondary objectives 1
- Neurological outcome at 30 days (mRS and GOS-E) ROSC Survival at 6 months Neurological outcome (mRS and GOS-E) at 6 months
Conditions and MedDRA coding
Cardiac arrest
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- In hospital cardiac arrest patients meeting criteria for adrenaline administration according to current ERC guidelines are eligible for the study
Exclusion criteria 1
- Patient under 18 years of age, Women considered of childbearing potential (WOCBP) i. e. premenopausal women
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Survival at 30 days
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Solu-Medrol 40 mg pulver och vätska till injektionsvätska, lösning
PRD547753 · Product
- Active substance
- Methylprednisolone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB04 — METHYLPREDNISOLONE
- Marketing authorisation
- 09408
- MA holder
- PFIZER AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Solu-Cortef 100 mg pulver och vätska till injektionsvätska, lösning.
PRD566975 · Product
- Active substance
- Hydrocortisone
- Substance synonyms
- CORTISOL
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB09 — HYDROCORTISONE
- Marketing authorisation
- 05561
- MA holder
- PFIZER AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Empressin 40 IE/2 ml koncentrat till infusionsvätska, lösning
PRD7094020 · Product
- Active substance
- Argipressin
- Substance synonyms
- ARGININE VASOPRESSIN
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 IU international unit(s)
- Max total dose
- 100 IU international unit(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- H01BA01 — VASOPRESSIN
- Marketing authorisation
- 55407
- MA holder
- ORPHA-DEVEL HANDELS UND VERTRIEBS GMBH
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Adrenalin Aguettant 0,1 mg/ml, injektionsvätska, lösning i förfylld spruta
PRD8364439 · Product
- Active substance
- Epinephrine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- C01CA24 — EPINEPHRINE
- Marketing authorisation
- 52213
- MA holder
- LABORATOIRE AGUETTANT
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Tiohundra AB
- Sponsor organisation
- Tiohundra AB
- Address
- Roslagsgatan 6
- City
- Norrtälje
- Postcode
- 761 31
- Country
- Sweden
Scientific contact point
- Organisation
- Tiohundra AB
- Contact name
- Sune Forsberg
Public contact point
- Organisation
- Tiohundra AB
- Contact name
- Sune Forsberg
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Expired | 1,400 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Sweden | 2022-12-19 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-02-28 | Sweden | Acceptable 2022-03-28
|
2022-03-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2022-05-24 | Sweden | Acceptable 2022-08-29
|
2022-08-30 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2022-09-01 | Sweden | Acceptable 2022-08-29
|
2022-09-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2022-09-02 | Sweden | Acceptable 2022-08-29
|
2022-09-02 |