Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest (NCT02035839) | Clinical Trial Compass
CompletedNot Applicable
Finding the Optimal Cooling tempeRature After Out-of-HoSpiTal Cardiac Arrest
Germany, Spain150 participantsStarted 2014-03
Plain-language summary
To assess the fraction of subjects surviving with good neurological outcome at 90 days for 3 different levels of hypothermia, in comatose survivors from out-of-hospital cardiac arrest.
Who can participate
Age range
18 Years – 80 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:
* Signed informed consent (obtained from their legal representative)
* 18 years of age or older and less than 80 years old.
* Witnessed OHCA of presumed cardiac cause
* Sustained ROSC (when chest compressions have not been required for 20 consecutive minutes and signs of circulation persist)
* Initial shockable cardiac rhythm (documented by ECG or AED)
* Interval from collapse to advance life support \< 20 minutes
* Interval from collapse to ROSC \< 60 minutes
* Lack of meaningful response to verbal commands upon arrival to hospital after suffering non-traumatic cardiac arrest in an out-of-hospital setting
* Systolic blood pressure of \>90 maintained for a least 30 minutes post-ROSC without pressors, or with a stable dose of pressors
Exclusion Criteria:
* Traumatic cardiac arrest
* Toxicological etiology
* Known or suspected pregnancy
* Do Not Attempt to Resuscitate order in force
* Unwitnessed arrest
* In-Hospital arrest
* Anatomy, previous surgery or disease state contraindicating femoral venous access
* Received neuromuscular blocking agents prior to assessing level of consciousness following ROSC
* Neurological evaluation insufficient/incomplete after ROSC but prior to randomization.
* Body core temperature \< 34ºC at randomization
* Current Inferior Vena Cava (IVC) filter
* Known history of acute neurological illness or severe functional disabilities prior to arrest (e.g., seizures, traumatic brain injury, increased intracranial pressures, intra-ce…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
Fraction of subjects surviving with good neurologic outcome(modified Rankin Score (mRS) ≤ 3) at 90 days after out-of-hospital cardiac arrest.
Timeframe: at 90 days after out-of-hospital cardiac arrest