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← Back to the studies fieldPERMANENT CTIS TRIAL DOSSIER

2022-500596-32-00

Effect of xenon on brain injury, neurological outcome and survival in patients after aneurysmal subarachnoid hemorrhage

Public registry stateAuthorised
CLAIM BOUNDARY

This dossier documents a medicinal trial—not proof of efficacy.

Registration, authorisation of a trial application, trial start, result disclosure and marketing authorisation are different facts. The dossier claims neither clinical efficacy nor safety, deployment or causality.

CTIS record ≠ efficacy ≠ marketing authorisation
REGISTRY FACTS

What CTIS publishes about this trial

EUCT number
2022-500596-32-00
Trial status
Authorised
Sponsor
not published
Trial region
EEA
Phase
4
Trial category
2
Low-intervention trial
no
Estimated EU start
01 October 2024
Decision date
22 June 2022
Published
03 December 2025
Estimated end
01 December 2035
EXACT AI EVIDENCE

The original text determines inclusion.

Terms count only in allowlisted public CTIS fields. Sponsor, medical condition, phase or a generic software reference alone is not AI evidence.

“Development of prognostication models with a selected combination of brain imaging, biomarkers, clinical data and metabolomics by applying artificial intelligence and machine learning for EBI within first 72 hours after start of aSAH symptoms , vasospasm (within 21 days after start of SAH symptoms) and DCI (between day 4 and 6 weeks after s…”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[9].endPoint
Matched term
artificial intelligence
“Development of prognostication models with a selected combination of brain imaging, biomarkers, clinical data and metabolomics by applying artificial intelligence and machine learning for EBI within first 72 hours after start of aSAH symptoms , vasospasm (within 21 days after start of SAH symptoms) and DCI (between day 4 and 6 weeks after start of SAH symptoms…”
Source field
authorizedApplication.authorizedPartI.trialDetails.trialInformation.endPoint.secondaryEndPoints[9].endPoint
Matched term
machine learning
MEDICAL CONTEXT

Conditions and therapeutic areas

Reported medical conditions

  • Aneyrysmal subarachnoid hemorrhage needing ventilatory care in intensive care unit

Therapeutic areas

  • Diseases [C] - Nervous System Diseases [C10]10
COUNTRY TRACKS

Every country retains its own published state.

A status in one country is not transferred to another. Decision dates and status histories remain separate source facts.

Finland

Authorised
First decision
22 June 2022
Latest decision
02 April 2025
  1. Authorised
  2. Authorised
  3. Authorised
  4. Authorised
  5. Authorised
  6. Authorised
  7. Authorised
  8. Authorised
  9. Authorised
  10. Authorised
  11. Authorised
  12. Authorised
  13. Authorised
TRIAL APPLICATIONS

Submission, decision and country state remain separate

IN

INITIAL

Authorised
Trial status
Authorised
Submitted
30 May 2022
Decided
22 June 2022

Decisions22 June 2022 · Authorized

Country statusFinland · Authorised

SM-1

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
14 March 2023
Decided
06 June 2023

Decisions06 June 2023 · Authorized Conditions

Country statusFinland · Authorised

NSM-1

NON SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
30 November 2023
Decided
30 November 2023

Decisions30 November 2023 · Authorized

Country statusFinland · Authorised

SM-3

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
28 May 2024
Decided
05 June 2024

Decisions05 June 2024 · Authorized

Country statusFinland · Authorised

SM-6

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
21 August 2024
Decided
30 September 2024

Decisions30 September 2024 · Authorized

Country statusFinland · Authorised

SM-7

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
06 March 2025
Decided
02 April 2025

Decisions02 April 2025 · Authorized

Country statusFinland · Authorised

SM-8

SUBSTANTIAL MODIFICATION

Authorised
Trial status
Authorised
Submitted
31 October 2025
Decided
02 December 2025

Decisions02 December 2025 · Authorized

SOURCE-DATED CHRONICLE

Official dates, not an efficacy narrative.

The chronicle sorts published CTIS events. i6eal observation times follow on a separate clock.

  1. Application Submitted

    Application IN · Authorised

  2. Country Assessment

    Finland · Application IN · Authorized

  3. Application Status

    Application IN · Authorised

  4. Country Decision

    Finland · Application IN · Authorized

  5. Application Submitted

    Application SM-1 · Authorised

  6. Country Assessment

    Finland · Application SM-1 · Authorized

  7. Application Status

    Application SM-1 · Authorised

  8. Country Decision

    Finland · Application SM-1 · Authorized Conditions

  9. Application Submitted

    Application NSM-1 · Authorised

  10. Application Status

    Application NSM-1 · Authorised

  11. Country Decision

    Finland · Application NSM-1 · Authorized

  12. Application Submitted

    Application SM-3 · Authorised

  13. Application Status

    Application SM-3 · Authorised

  14. Country Decision

    Finland · Application SM-3 · Authorized

  15. Application Submitted

    Application SM-6 · Authorised

  16. Country Assessment

    Finland · Application SM-6 · Authorized

  17. Application Status

    Application SM-6 · Authorised

  18. Country Decision

    Finland · Application SM-6 · Authorized

  19. Application Submitted

    Application SM-7 · Authorised

  20. Country Assessment

    Finland · Application SM-7 · Authorized

  21. Application Status

    Application SM-7 · Authorised

  22. Country Decision

    Finland · Application SM-7 · Authorized

  23. Application Submitted

    Application SM-8 · Authorised

  24. Application Status

    Application SM-8 · Authorised

  25. Country Decision

    Finland · Application SM-8 · Authorized

  26. Trial Status Observed

    Authorised

Observed by i6eal
First observed
23 Jul 2026, 13:19
Last observed
23 Jul 2026, 15:03
Materially modified
23 July 2026
RESULT DISCLOSURE

Disclosure is a separate registry fact.

No result disclosure is published in this projection. This means neither that results do not exist nor that a deadline has been missed.

PROVENANCE

From the dossier back to the official record

The public CTIS record remains authoritative. The i6eal files are a deterministic, bounded projection.

Open public CTIS record ↗Open CTIS retrieval source ↗Machine-readable dossier · JSON ↓Structured metadata · JSON-LD ↓
i6eal (2026): EU AI Studies Monitor, CTIS trial 2022-500596-32-00, data state 23 July 2026. https://i6eal.de/en/tools/ki-studienmonitor/studie/2022-500596-32-00/
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