Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-27 @ 7:03 AM
Study NCT ID:
NCT05706194
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-01-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Neuroprognostication After OHCA
Sponsor:
Lund University
Organization:
Study Overview
Official Title:
Early Neurological Prognostication of Outcome After Out-of-hospital Cardiac arrest-a STEPCARE Prospective Substudy
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational substudy of the STEPCARE trial ClinicalTrials.gov Identifier: NCT05564754) with the aim to examine whether prognostication of neurological outcome after cardiac arrest can be performed earlier than the 72 h time-point recommended by guidelines today.
Detailed Description:
Hypotheses
1. The combination of clinical examination, the brain injury marker neurofilament light (NFL), electroencephalography (EEG), and head computed tomography (CT) predicts poor functional outcome already at 24 h post-arrest without false positive predictions.
2. Any guideline recommended method (EEG/CT/SSEP/clinical examination) fulfilling criteria for a poor outcome will have highly elevated blood levels of NFL, indicating the presence of severe brain injury.
3. Extensive sedation will not affect the prognostic accuracy of our prognostic methods EEG, NFL and CT.
Material and methods
The STEPCARE trial The patient population is adult patients with an out-of-hospital cardiac arrest with a presumed cardiac or unknown cause of arrest randomised in the STEPCARE trial (Sedation, TEmperature and Pressure after out-of-hospital Cardiac Arrest and REsuscitation, ClinicalTrials.gov Identifier: NCT05564754). The STEPCARE trial is an investigator initiated 2x2x2 international multicentre trial which will randomise patients to three intensive care interventions: minimal or higher levels of sedation, fever treatment versus no fever treatment and two different blood pressure targets. The aim of STEPCARE is to examine whether the interventions improves survival or functional outcome after CA. The statistical calculations indicate that 3500 patients are required to obtain sufficient power for our research questions. Patients will be recruited from more than 80 hospitals who have participated in the previous cardiac arrest trials initiated by the Lund University Center for Cardiac Arrest namely the TTM- and TTM2-trials (the to date largest published cardiac arrest trials).
The STEPCARE EARLY-NEURO substudy We will prospectively recruit participating sites who commit to follow the study protocol for participation in the biobank, and routinely examine patients' unconscious at 24 hours with EEG and CT as early as possible after 24 h. Serum and plasma blood samples will be collected prospectively at 12 h, 24 h, 48 h and 72 h post-randomisation, processed on site and transported to the Integrated Biobank in Luxembourg for storage. Biochemical analyses of NFL will be performed in batch after trial completion. The original EEG recordings, SSEP and neuroimaging (CT and MRI) will be collected for central blinded evaluation by study investigators. All patient data will be stored using patients study ID as identification. All patients will be treated according to the STEPCARE trial protocol according to randomisation, treatment, and follow-up. Prediction of neurological outcome performed according to the ERC/ESICM guidelines ≥72 hours post-arrest. Decisions on withdrawal of life-sustaining therapy will not be based on the early examinations alone, but must follow ERC/ESICM recommendations. Functional outcome will be assessed at a face-to-face follow up after six months and classified according to the modified Rankin Scale (mRS). Poor functional outcome will be defined as mRS 4-6 (moderately severe disability, severe disability, or death).
1. The combination of clinical examination, the brain injury marker neurofilament light (NFL), electroencephalography (EEG), and head computed tomography (CT) predicts poor functional outcome already at 24 h post-arrest without false positive predictions.
2. Any guideline recommended method (EEG/CT/SSEP/clinical examination) fulfilling criteria for a poor outcome will have highly elevated blood levels of NFL, indicating the presence of severe brain injury.
3. Extensive sedation will not affect the prognostic accuracy of our prognostic methods EEG, NFL and CT.
Material and methods
The STEPCARE trial The patient population is adult patients with an out-of-hospital cardiac arrest with a presumed cardiac or unknown cause of arrest randomised in the STEPCARE trial (Sedation, TEmperature and Pressure after out-of-hospital Cardiac Arrest and REsuscitation, ClinicalTrials.gov Identifier: NCT05564754). The STEPCARE trial is an investigator initiated 2x2x2 international multicentre trial which will randomise patients to three intensive care interventions: minimal or higher levels of sedation, fever treatment versus no fever treatment and two different blood pressure targets. The aim of STEPCARE is to examine whether the interventions improves survival or functional outcome after CA. The statistical calculations indicate that 3500 patients are required to obtain sufficient power for our research questions. Patients will be recruited from more than 80 hospitals who have participated in the previous cardiac arrest trials initiated by the Lund University Center for Cardiac Arrest namely the TTM- and TTM2-trials (the to date largest published cardiac arrest trials).
The STEPCARE EARLY-NEURO substudy We will prospectively recruit participating sites who commit to follow the study protocol for participation in the biobank, and routinely examine patients' unconscious at 24 hours with EEG and CT as early as possible after 24 h. Serum and plasma blood samples will be collected prospectively at 12 h, 24 h, 48 h and 72 h post-randomisation, processed on site and transported to the Integrated Biobank in Luxembourg for storage. Biochemical analyses of NFL will be performed in batch after trial completion. The original EEG recordings, SSEP and neuroimaging (CT and MRI) will be collected for central blinded evaluation by study investigators. All patient data will be stored using patients study ID as identification. All patients will be treated according to the STEPCARE trial protocol according to randomisation, treatment, and follow-up. Prediction of neurological outcome performed according to the ERC/ESICM guidelines ≥72 hours post-arrest. Decisions on withdrawal of life-sustaining therapy will not be based on the early examinations alone, but must follow ERC/ESICM recommendations. Functional outcome will be assessed at a face-to-face follow up after six months and classified according to the modified Rankin Scale (mRS). Poor functional outcome will be defined as mRS 4-6 (moderately severe disability, severe disability, or death).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: