Swiss SOS MoCA - DCI Study (NCT03032471) | Clinical Trial Compass
TerminatedNot Applicable
Swiss SOS MoCA - DCI Study
Stopped: COVID-restrictions on clinical research in Switzerland
Switzerland128 participantsStarted 2017-07-20
Plain-language summary
The primary objective of this multicenter observational study is to determine the effect size of the relationship between DCI and neuropsychological impairment 14-28 days and 3 months after aSAH.
Secondary objectives are the feasibility to administer and the validity of the MoCA in an intensive care unit setting, as well as the test/retest reliability of the MoCA in patients with acute brain damage in absence of aSAH.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
For part 1 of the study:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
* Consent of the patient or consent of patient's next of kin (plus consent of an independent physician if patient is unable to consent)
* Aneurysmal SAH
* Age: ≥18
* Time of aSAH known (IMPORTANT: at least approximated. Time of aSAH refers to the bleed that lead to hospital admission; warning leaks in the patient history are not considered aSAH in this context)
* Complete aneurysm occlusion therapy within 48h after aSAH
* Glasgow coma scale (GCS) ≥ 13 points at time point 48h - 72h after aSAH
* Fluent language skills in either English, German, French, or Italian
For part 2 of the study:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
* Consent of the patient or consent of patient's next of kin (plus consent of an independent physician if patient is unable to consent)
* Age: ≥18
* Acute brain injury that requires a in-patient treatment, e.g. for (surgical) treatment of a brain tumor, a cerebral hemorrhage, a hydrocephalus, stroke, or traumatic brain injury, with stable neurological and general health status
* Glasgow coma scale (GCS) ≥ 13 points
* Fluent language skills in either English, German, French, or Italian
Exclusion Criteria:
For part 1 of the study:
The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
* SAH due to any other cause …