Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Trial · NCT07896655
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Distribution of Modified Rankin Scale Scores at 90 Days | 90 (±7) days after randomization | The distribution of modified Rankin Scale (mRS) scores at 90 (±7) days after randomization will be assessed across all seven categories (0-6) using a shift analysis. Scores range from 0 (no symptoms) to 6 (death); lower scores indicate less disability. |
| Secondary | mortality at 90 (±7) days | 90 (±7) days after randomization | All-cause mortality at 90 (±7) days after randomization. |
| Secondary | Independent ambulation | 90 (±7) days after randomization | The proportion of participants with a modified Rankin Scale (mRS) score of 0-3 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability. |
| Secondary | Functional independence | 90 (±7) days after randomization | The proportion of participants with a modified Rankin Scale (mRS) score of 0-2 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability. |
| Secondary | Excellent outcome | 90 (±7) days after randomization | The proportion of participants with a modified Rankin Scale (mRS) score of 0-1 at 90 (±7) days after randomization will be assessed. The mRS ranges from 0 (no symptoms) to 6 (death); lower scores indicate less disability. |
| Secondary | Quality of life score | 90 (±7) days after randomization | Health-related quality of life at 90 (±7) days after randomization will be assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Index scores calculated using the Chinese value set range from -0.391 (the worst health state) to 1 (full health); higher scores indicate better health-related quality of life. |
| Secondary | Cerebral infarction volume | Between 72 hours and 7 days after the procedure | Cerebral infarction volume measured on CT or diffusion-weighted MRI obtained between 72 hours and 7 days after the procedure (MRI preferred). |
| Secondary | Vascular Re-occlusion Rate | Between 24 hours and 7 days after the procedure | Proportion of participants with re-occlusion of the originally occluded artery or a distal vessel, assessed by CTA or MRA between 24 hours and 7 days after the procedure. |
| Other | Symptomatic Intracranial Hemorrhage Within 72 Hours | Within 72 hours after the procedure | The proportion of participants who develop symptomatic intracranial hemorrhage within 72 hours after the procedure will be assessed according to the Heidelberg Bleeding Classification. Symptomatic intracranial hemorrhage is defined as a new hemorrhage identified on brain imaging associated with neurological deterioration, indicated by an increase of ≥4 points in the total National Institutes of Health Stroke Scale (NIHSS) score, an increase of ≥2 points in a single NIHSS item, or deterioration requiring a major medical or surgical intervention, such as intubation, decompressive hemicraniectomy, or external ventricular drainage, with no alternative explanation for the deterioration. Changes in NIHSS scores are measured relative to the assessment immediately before deterioration. Total NIHSS scores range from 0 to 42, with higher scores indicating greater neurological impairment. This outcome is recorded as present or absent; the Heidelberg Bleeding Classification does not yield a numer |
| Other | Any Intracranial Hemorrhage | Through day 7 (±1 day) after the procedure or discharge, whichever occurs first | The proportion of participants with any intracranial hemorrhage detected on protocol-specified computed tomography (CT) or magnetic resonance imaging (MRI) will be assessed through day 7 (±1 day) after the procedure or discharge, whichever occurs first. Both symptomatic and asymptomatic hemorrhages will be included. Hemorrhages will be categorized according to the Heidelberg Bleeding Classification, which describes the anatomical location and pattern of bleeding and does not yield a numerical total score. This outcome is recorded as present or absent; minimum and maximum scale scores are not applicable. A higher proportion indicates a worse safety outcome. |
| Other | Severe Pneumonia | Periprocedural | Proportion of participants with a new pulmonary infection confirmed by chest imaging that requires endotracheal intubation, re-intubation after extubation due to pneumonia, prolongation of existing intubation by at least 48 hours for pneumonia treatment, or tracheostomy. |
| Other | Fatal Perioperative Arrhythmia | Periprocedural | Proportion of participants who experience a perioperative cardiac arrhythmia resulting in death. |
| Other | Cerebral herniation | Periprocedural | Proportion of participants who develop cerebral herniation. |
| Other | Bradycardia | Periprocedural | Proportion of participants with bradycardia, defined as a heart rate below 50 beats per minute lasting longer than 1 minute. |
| Other | Coagulation Abnormalities | Periprocedural | Proportion of participants who develop a coagulation abnormality, including abnormal clotting that may result in excessive bleeding or abnormal blood clot formation. |
| Other | Electrolyte Disturbances | Periprocedural | Proportion of participants who develop an electrolyte disturbance. |
| Other | Intracranial Vasospasm | Periprocedural | Proportion of participants who develop intracranial vasospasm. |
| Other | Deep Vein Thrombosis | Periprocedural | Proportion of participants who develop deep vein thrombosis during the index hospitalization. |
| Other | All-Cause Mortality at 12 Months | From randomization through 12 months (±30 days) | Proportion of participants who die from any cause within 12 months after randomization. |
| Other | Distribution of Modified Rankin Scale Scores at 12 Months | 12 months (±30 days) after randomization | The distribution of modified Rankin Scale (mRS) scores at 12 months (±30 days) after randomization will be assessed across all seven categories (0-6) using a shift analysis. Scores range from 0 (no symptoms) to 6 (death); lower scores indicate less disability. |
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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