CompletedNot Applicable

Study for the Improvement of Long-Term Outcome Prediction in Patients in Coma After Cardiac Arrest

Germany150 participantsStarted 2014-10

Plain-language summary

The primary objective of HOPE is to improve the accuracy of outcome prediction in anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some of the existing methods used for this purpose (e.g. somato-sensory evoked potentials). HOPE is the first multicenter prospective cohort study on coma prognosis to control for the effect of a possible self-fulfilling prophecy at the ICU and to cover the acute and neurorehabilitation phases with a long-term follow-up longer than the usual three or six months.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age between 18 and 85 years * Cause of admission to ICU: cardiac arrest (in or out of hospital) * Glasgow-Coma-Scale \< 9 at time of study enrolment (3 to 8 days after cardiac arrest) * Informed consent signed by legal guardian/next-of-kin Exclusion Criteria: * Stroke (as it may interfere with SSEP testing) * Pre-existing coma/vegetative state/minimally conscious state * Terminal malignant disease * Survival in the next 12 months extremely unlikely * Existing advanced directive that demands cessation of therapy/life support * Palliative care/withdrawal of life support during treatment at the ICU * Barbiturate-induced general anesthesia during the first 3 days after cardiac arrest * Impossibility of assessing current level of consciousness with the Glasgow Coma Scale due to a long-term deep sedation

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study focused on predicting long-term outcomes for people in a coma after cardiac arrest — if my loved one is in this situation, how does the Coma Recovery Scale that was used in this trial compare to the tools your team is currently using to assess their level of consciousness?
2Since this trial has already been completed, has the research produced any published findings about which early signs are most reliable for predicting recovery from anoxic-ischemic encephalopathy, and would those findings change anything about how you're approaching my loved one's care?
3The study was observational and focused on prediction rather than a new treatment — does that mean it might inform a prognosis conversation rather than open up a new therapy option, and how should we weigh that kind of information right now?
4Given that this trial was about improving outcome prediction, what does current evidence actually say about the range of possible recoveries from a coma caused by lack of oxygen to the brain, and how confident can you be in any early prediction you give us?
5Are there other active trials or standard-of-care approaches for anoxic-ischemic encephalopathy that we should be considering alongside what this completed study found?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Current level of consciousness as measured by the revised version of the Coma Recovery Scale (CRS-R)

Timeframe: There are 6 CRS-R data entry points distributed within a 12-month period, namely, 2 time points at the ICU, 3 time points during neurorehabilitation and 1 time point at the patient's residence 12 months after day 0.

Trial details

NCT IDNCT02231060

SponsorLudwig-Maximilians - University of Munich

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-12-06

View on ClinicalTrials.gov More Anoxic-Ischemic Encephalopathy trials