Trial · NCT06868511
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modified Rankin Scale (mRS) score of 0-3 at 180 days. | 180 ±14 days | The primary efficacy outcome is the proportion of patients achieving a favorable functional outcome, defined as a modified Rankin Scale (mRS) score of 0-3 at 180 days. |
| Secondary | Dichotomized eGOS (extended Glasgow Outcome Scale) score at 180 days: 4-8 (good) vs. 1-3(poor) | 180 ± 14 days | Dichotomized eGOS (extended Glasgow Outcome Scale) score at 180 days: 4-8 (good) vs. 1-3 (poor). The eGOS is scored as: 1=Death, 2=Vegetative state, 3=Lower severe disability, 4=Upper severe disability, 5=Lower moderate disability, 6=Upper moderate disability, 7=Lower good recovery, 8=Upper good recovery. |
| Secondary | All-cause death at 180 days | 180 ± 14 days | All-cause death at 180 days |
| Secondary | Dichotomized, modified Rankin Scale (mRS) Score 0-3 vs. 4-6 at 90 days. | 90 ± 7 days | Proportion of patients with mRS of 0-3 (good functional status) at 90 days. The mRS is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-3=No symptoms to moderate disability requiring some assistance; 4-6=Moderately severe disability requiring complete assistance to death. |
| Secondary | Dichotomized graded modified Rankin Scale (mRS) score at 180 days : 0-2 vs. 3-6. | 180 ± 14 days | Dichotomized graded modified Rankin Scale (mRS) score at 180 days post-hemorrhage: 0-2 vs. 3-6. The mRS is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. Dichotomized scores are: 0-2=No symptoms to slight disability; 3-6=Moderate disability requiring some assistance to death. |
| Secondary | Ordinal graded modified Rankin Scale (mRS) score (0-6) at 180 days. | 180 ± 14 days | Ordinal graded modified Rankin Scale (mRS) score (0-6) at 180 days. The mRS is scored from: 0=No symptoms at all, 1=No significant disability, 2=Slight disability, 3=Moderate disability, 4=Moderately severe disability, 5=Severe disability and 6=death. |
| Secondary | Barthel Index (BI) assessment at 180 days. | 180 ±14 days. | Barthel Index assessment at 180 days. The Barthel Index (BI) assesses ten functional tasks of daily living, and each task provides a measure for level of independence. Scores range from 0 and 100, with a higher score indicating greater independence. |
| Secondary | Extended Glasgow Outcome (eGOS) assessment at 180 days. | 180 ± 14 days | Extended Glasgow Outcome (eGOS) assessment at 180 days. The extended Glasgow Outcome Scale (eGOS) is a global scale for functional outcome with eight categories: 1 - Death, 2 - Vegetative State, 3 - Lower Severe Disability, 4 - Upper Severe Disability, 5 - Lower Moderate Disability, 6 - Upper Moderate Disability, 7 - Lower Good Recovery, 8 - Upper Good Recovery. |
| Secondary | The change of the National Institutes of Health Stroke Scale (NIHSS) at 5-7 days or discharge if earlier from baseline. | 5-7 days | The change of the National Institutes of Health Stroke Scale (NIHSS) at 5-7 days or discharge if earlier from baseline. Patients with a NIHSS score of less than 6 are considered to have a good recovery. The NIHSS is a 11-item scale that assesses language, motor function, sensory loss, consciousness, visual fields, extraocular movements, coordination, neglect, and speech. It is scored from 0 (no stroke symptoms) to 42 (severe stroke). |
| Secondary | Safety/Mortality - All-cause death at 30 days | Within 30 days. | All-cause death at 30 days |
| Secondary | Safety/Mortality - All-cause death at 7 days | Within 7 days | All-cause death at 7 days |
| Secondary | Safety/Mortality - Symptomatic rebleeding within 6 days | Within 6 days | Symptomatic rebleeding events within 6 days post-randomization (defined as a persistent decrease in GCS motor score by more than 2 points, with a CT scan showing a new hematoma with a CT value greater than 72 HU and a volume exceeding 5 ml within the hematoma cavity and surrounding area compared to the prior scan). |
| Secondary | Safety/Mortality - Intracranial bacterial infection within 30 days | Within 30 days | Intracranial bacterial infection within 30 days. |
| Secondary | Safety/Mortality - Total Adverse Events (AEs) within 30 and 180 days | Within 30 and 180 days | Total Adverse Events (AEs) across all coded organ systems that occurred within 30 and 180 days. |
| Secondary | Safety/Mortality - Total Serious Adverse Events (SAEs) within 30 and 180 days | Within 30 and 180 days | Total Serious Adverse Events (SAEs) within 30 and 180 days. |
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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