Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT06490835
Eligibility Criteria:
Both patients and surrogates must meet the inclusion criteria and not fall under any exclusion criteria
\[Inclusion Criteria\]
Patients:
1. Diagnosis of sudden and severe acute brain injury due to at least one of the following etiologies: vascular, traumatic, metabolic, toxic, infectious, or anoxic AND
2. Glasgow Coma Scale score of 3-8 for at least 24 hours after the patient's admission AND
3. Unable to express themselves verbally or otherwise
OR
1. Diagnosis of advanced stage organ failure (any of the following)
* Chronic lung disease requiring long-term oxygen therapy or mechanical ventilation
* Decompensated liver cirrhosis
* Chronic heart failure with NYHA class III or IV
* Progressive neurological disease with a modified Rankin score of 3-5 (e.g., dementia, Parkinson's disease, and amyotrophic lateral sclerosis)
* Three or more chronic comorbidities causing limitations in activities of daily living (ADL) AND
2. APACHE II score ≥ 14 at the time of screening AND
3. ICU stay of 7 days or more
Surrogates:
1. Family caregiver of a patient who meets the inclusion criteria (Family: defined as the patient's spouse, lineal ascendants and descendants within two degrees of kinship and their spouses, siblings and their spouses, and relatives within eight degrees of kinship and their spouses)
2. Aged 19 or older
3. Willing and able to provide consent for participation in the study
\[Exclusion Criteria\]
Patients:
1. Under 19 years of age
2. Unable to speak, understand, or read Korean
3. Refusal of palliative care consultation
4. Referred to palliative care prior to study enrollment
5. Within 48 hours of ICU admission
6. Presence of active cancer under treatment within 6 months prior to ICU admission
7. Care goals set to "comfort care" at the time of study enrollment
8. Death expected within 48 hours at the time of study enrollment
9. Lack of capacity to participate in the study without an appropriate surrogate
Surrogates:
1. Under 19 years of age
2. Unable to speak, understand, or read Korean
3. Determined by a physician to be in extremely poor health, making participation in the study infeasible
4. Refusal of palliative care consultation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Study:
NCT06490835
Study Brief:
Protocol Section:
NCT06490835