Trial · NCT05713630
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) | Every 2 weeks after randomization up to 45±10 days. | A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 - Global Health. English and French versions | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A 10-item measure that assesses an individual's general physical, mental, and social health as it is intended to globally reflect individuals' assessment of their physical and mental health in the last 7 days. |
| Secondary | PROMIS Item Bank v2.0 - Cognitive Function. English version | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A measure that assesses cognitive function that will be administered as a computer adaptive test. |
| Secondary | PROMIS Item Bank v2.0 - Physical Function. English version | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A measure that assesses self-reported capability rather than actual performance of physical activities that will be administered as a computer adaptive test. |
| Secondary | PROMIS Item Bank v2.0 - Ability to Participate in Social Roles and Activities. English version | Baseline and every 2 weeks after randomization up to 45±10 days, and then at 60-90 days, and 180±10 days after randomization. | A measure that assesses the perceived ability to perform one's usual social roles and activities that will be administered as a computer adaptive test. The item bank does not use a time frame (e.g. over the past 7 days) when assessing ability to participate in social roles and activities. |
| Secondary | Subdural hematoma volume change | Baseline, 45±10 days after randomization, and 60-90 days if deemed necessary for the patient's routine care. | Change in hematoma volume in millilitres on CT scan. |
| Secondary | Number of subdural hematoma-related surgical interventions | First admission, subsequent admissions up to 180 days after randomization | |
| Secondary | Recurrence rate of SDH | 45±10 days, 60-90 days, and 180±10 days after randomization | |
| Secondary | Mortality | During the course of study up to 180±10 days after randomization | |
| Secondary | Modified Rankin Scale | Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization | A 6-point disability scale used to measure the degree of disability in patients who have had a stroke. |
| Secondary | Disability Rating Scale | Baseline, 45±10 days, 60-90 days, and 180±10 days after randomization | Eight questions regarding body function, activity, participation, communication, and movements each rated on a 3-5-point scale that is summed to give a total score. |
| Secondary | Montreal Cognitive Assessment | Baseline, 45±10 days, and 60-90 days after randomization | This assessment evaluates the patient's cognition based on eight areas: visuospatial/executive function, naming, memory, attention, language, abstraction, delayed recall, and orientation. |
| Secondary | Medical Consumption Questionnaire | Baseline, 45±10 days, and 180±10 days after randomization | Health-related cost questionnaire on the use of healthcare in the past month. |
| Secondary | EQ-5D-5L | Baseline, 60-90 days, and 180±10 days after randomization | A self-rated questionnaire that assesses a patient's health state in five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. |
| Secondary | Adverse events | Discharge, 45±10 days, 60-90 days, and 180±10 days after randomization | Adverse events of grade 3 or higher as defined by Good Clinical Practice Guidelines. |
| Secondary | Length of stay in hospital due to subdural hematoma | During the course of the study up to 180±10 days after randomization | |
| Secondary | Disposition after discharged from hospital | During the course of the study up to 180±10 days after randomization | |
| Secondary | Groningen Frailty Indicator | Baseline and 45±10 days after randomization. | A 15-item questionnaire assessing mobility, vision, hearing, nutrition, comorbidity, cognition, psychosocial and physical well-being. Each item is scored dichotomously, with a value of 1 assigned when a deficit is present. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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