Predictive Outcome in Comatose Patients
PRECOM
New Predictive Tool of Awakening in Comatose Patients in the Intensive Care Unit
1 other identifier
observational
100
1 country
7
Brief Summary
Evaluating the prognosis of comatose patients after cardiac arrest (CA) in the intensive care unit (ICU) remains challenging. It requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations, (among them auditive evoked potentials or AEP) but none has a sufficient sensitivity/specificity. In a preliminary study, the investigators developed an algorithm from the signal collected with AEP, and generated a probability map to visually classify the participants after the algorithm processing. Participants could be classified either with a good neurological prognosis or with bad neurological prognosis or death. The investigators hypothesize that the "PRECOM" tool, applied blindly to a large prospective multicenter cohort of patients admitted to intensive care for coma in the aftermath of CA will predict neurological prognosis at 3 months with high sensitivity and specificity.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2023
Longer than P75 for all trials
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 14, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
November 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 29, 2028
December 23, 2025
December 1, 2025
4.3 years
March 14, 2022
December 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Awakening within 3 months
Awakening is defined as normal motor activity in response to the 3 instructions for the motor component M of the FOUR score (show your thumb, make the V for victory and show your fist; M = 4). This criterion will be collected by the doctor in charge of the patient at the time of the assessment and will be dated.
within 3 months ± 2 weeks after inclusion
Secondary Outcomes (17)
CPC score within 3 months
3 months ± 2 weeks after inclusion
mRS score within 3 months
3 months ± 2 weeks after inclusion
FOUR score within 3 months
3 months ± 2 weeks after inclusion
GOSE score within 3 months
3 months ± 2 weeks after inclusion
CPC score within 6 months
6 months ± 2 weeks after inclusion
- +12 more secondary outcomes
Study Arms (1)
Comatose patients in intensive care unit
Patient admitted in the intensive care unit (ICU) for post cardiac arrest (CA) coma, persistent for at least 3 days after CA.
Interventions
In usual practice, in intensive care unit, evaluating the neurological prognosis of comatose patients after cardiac arrest requires a multimodal approach combining standardized clinical examination, serum biomarkers, imaging and classically electrophysiological examinations (among them auditive evoked potentials or AEP). An algorithm (PRECOM tool) which has been previously developed from the signal extracted from AEP allows to visually classify the patients after processing signal by the algorithm in a cluster of points with a high specificity into "good neurological prognosis" and "bad neurological prognosis". The AEP signals recorded in the 1st and 2nd week of patient inclusion are to be collected by the neurophysiologist. At the end of the patient's participation in the study, these data will be encrypted, anonymized and transmitted to the mathematician to be processed by the PRECOM tool.
Eligibility Criteria
Adult patients admitted to intensive care following a cardica arrest.
You may qualify if:
- Age above18 years old
- Patient affiliated to a French Heath Care Insurance
- Admitted in the intensive care unit (ICU) for coma post extra- or intra-hospital cardiac arrest (CA) with shockable or non-shockable rhythm
- Persistent coma on day 3 after post CA, defined by the inability to respond to a verbal command in an appropriate manner (motor Glasgow components ≤ 3) and at the time of neurophysiological recordings (D3-D7 ± week -end).
You may not qualify if:
- Decision to limit resuscitation therapies taken by the resuscitation team
- Inability to perform the auditory evoked potentials (AEP) (deafness, skin lesion or any condition preventing to record AEP).
- Opposition by the trusted person or by the patient once he/she wakes up
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
APHP Avicenne Hospital - Réanimation médico-chirurgicale
Bobigny, 93000, France
APHP Lariboisière Hospital, Clinical Physiology Department
Paris, 75010, France
APHP Laribosière Hospital - Service de Réanimation Médical et Toxicologique
Paris, 75010, France
APHP Cochin Hospital - médecine intensive-réanimation
Paris, 75014, France
APHP HEGP hospital - Réanimation médicale
Paris, 75015, France
APHP Bichat Hospital -Médecine intensive - réanimation infectieuse
Paris, 75018, France
Delafontaine Hospital - médecine intensive-réanimation
Saint-Denis, 93200, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nathalie KUBIS, Md,PhD
APHP Lariboisière Hospital, Clinical Physiology Department
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2022
First Posted
April 11, 2022
Study Start
November 15, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
May 29, 2028
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share