The Danish Out-of-Hospital Cardiac Arrest study (DANOHCA)

Phase 1

• Conditions: We will investigate the efficacy of four interventions (two pharmaceutical) for reducing mortality and organ damage in patients resuscitated after out-of-hospital cardiac arrest.; MedDRA version: 20.0Level: LLTClassification code 10003109Term: Arrest cardiacSystem Organ Class: 100000004849; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-005876-21-DK
• Lead Sponsor: Department of Cardiology, Copenhagen University Hospital, Rigshospitalet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-12-20
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Age =18 years
2. OHCA of presumed cardiac cause
3. Sustained ROSC#
4. Unconsciousness (GCS <9) (patients not able to obey verbal commands) after sustained ROSC at the time of randomization

# Sustained ROSC: Sustained ROSC is when chest compressions or mechanical circulatory support have been not required for 20 consecutive minutes and signs of circulation persist.

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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 700

Exclusion Criteria

1. Females of childbearing potential (unless a negative HCG test can rule out pregnancy within the inclusion window)
2. Known bleeding diathesis (medically induced coagulopathy (e.g. warfarin, NOAC, clopidogrel) does not exclude the patient)
3. Suspected or confirmed acute intracranial bleeding
4. Suspected or confirmed acute stroke
5. Unwitnessed asystole
6. Known limitations in therapy and Do Not Resuscitate-order
7. Known disease making 180 days survival unlikely
8. Known pre-arrest CPC 3 or 4 functional status
9. >3 hours (180 minutes) from ROSC to screening
10. Systolic blood pressure <80 mm Hg despite fluid loading/vasopressor and/or inotropic medication#
11. Use of intra-aortic balloon pump/axial flow device/ECMO†
12. Temperature on admission <30°C

Further exclusion criteria specific to the trial interventions:
13. Known allergy from dexamethasone or olanzapine
14. Ongoing (within 48 h) treatment with dexamethasone or olanzapine
15. Known back or hip condition that precluded the patients from being positioned with backrest from 0 to 45-degree angle
16. Known or suspected Long QT Syndrome (LQTS)
17. Known active fungal disease. Localized skin lesions do not exclude patients from inclusion
18. Estimated body weight <45kg

# If the systolic blood pressure (SBP) is recovering during the inclusion window (180 minutes) the patient may be included
† If the patient is weaned and the device is removed during the inclusion window (180 minutes) the patient may be included

Study & Design

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