Trial · NCT07882784
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Unfavourable functional outcome at 12 months (modified Rankin Scale 4-6) | 12 months after ICH onset | Proportion of participants with mRS 4-6 (unfavourable) versus 0-3. The mRS ranges from 0 (no symptoms) to 6 (death); higher scores indicate worse outcome. Used as the outcome of the multivariable prognostic model. |
| Secondary | Functional outcome on the full ordinal modified Rankin Scale at 12 months | 12 months after ICH onset | Distribution of mRS scores (0 = no symptoms to 6 = death; higher scores indicate worse outcome), analysed with proportional odds regression. |
| Secondary | Functional outcome at 6 months (modified Rankin Scale) | 6 months after ICH onset | mRS score (0 = no symptoms to 6 = death; higher scores indicate worse outcome). |
| Secondary | All-cause mortality | 30 days, 6 months and 12 months after ICH onset | Proportion of participants who died from any cause. |
| Secondary | Change in neurological deficit (NIHSS) during hospitalisation | Admission, approximately 48 hours, and hospital discharge (up to approximately 4 weeks) | National Institutes of Health Stroke Scale score (0-42; higher scores indicate more severe deficit). |
| Secondary | Neurological deficit at follow-up (NIHSS) | 6 and 12 months after ICH onset | National Institutes of Health Stroke Scale score (0-42; higher scores indicate more severe deficit). |
| Secondary | Pain burden during hospitalisation | From admission to hospital discharge (up to approximately 4 weeks) | Pain assessed hierarchically according to communication ability: Numeric Rating Scale 0-10 (higher = more pain) in communicative patients; Behavioural Pain Scale, revised Nociception Coma Scale, PAIC15 or Doloplus-2 in non-communicative patients. |
| Secondary | Pain intensity at follow-up (Numeric Rating Scale) | 6 and 12 months after ICH onset | Numeric Rating Scale 0-10 (0 = no pain, 10 = worst imaginable pain). |
| Secondary | Health-related quality of life (PROMIS-29) | 6 and 12 months after ICH onset | PROMIS-29 domain T-scores (physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles, pain interference) and pain intensity item. Higher scores indicate more of the domain measured. |
| Secondary | Self-rated health (EQ-5D VAS) | 6 and 12 months after ICH onset | EuroQol visual analogue scale, 0 (worst imaginable health) to 100 (best imaginable health). |
| Secondary | Intensive care unit length of stay | From admission to hospital discharge (up to approximately 4 weeks) | Days in the intensive care unit. |
| Secondary | ICU-to-ward transition time | From admission to hospital discharge (up to approximately 4 weeks) | Time from admission to transfer from the intensive care unit to a ward, in days. |
| Secondary | Total hospital length of stay | From admission to hospital discharge (up to approximately 4 weeks) | Days from admission to discharge. |
| Secondary | Discharge destination | At hospital discharge (up to approximately 4 weeks) | Categories such as home, inpatient rehabilitation, long-term care facility, other hospital, or death. |
| Secondary | Rehabilitation exposure | From admission to 12 months after ICH onset | Type, setting and amount of rehabilitation received. |
| Secondary | Hospital readmissions | Up to 12 months after ICH onset | Number of participants readmitted and number of readmissions. |
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.
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GET https://conductscience.org/api/trials/v1/NCT07882784/registered