Trial · NCT05995405
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 | Incidence (% or proportion) of subjects with at least one episode of clinically significant hypotension with a reasonable possibility that GTX-104/oral nimodipine caused the event, according to the Endpoint Adjudication Committee. | 90 days | Hypotension events requiring medical treatment |
| Secondary | Total number of episodes of clinically significant hypotension | Day 1 - Day 90 | |
| Secondary | Duration of episodes of clinically significant hypotension | Day 1 - Day 90 | Calendar days |
| Secondary | Incidence and severity of Adverse Events (AEs) based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 5.0). | Day 1 - Day 90 | |
| Secondary | Incidence of delayed cerebral ischemia (DCI) | Day 1 - Day 21 | Delayed cerebral ischemia will be evaluated and defined by the following: * For subjects in whom changes in the mGCS and Abbreviated National Institutes of Health Stroke Scale (aNIHSS) are assessable: a decrease of at least 2 points on the mGCS or an increase of at least 2 points on the aNIHSS, lasting for at least 2 hours, where other medical or surgical causes are excluded. The deterioration is measured relative to the best score attained after aneurysm repair. * For subjects in whom the neurologic scales are not assessable: radiological evidence and clinical judgement. |
| Secondary | Use of rescue therapy for DCI | Day 1 - Day 21 | Rescue therapy is defined as induced hypertension, selective intraarterial infusion of vasodilator drugs or balloon angioplasty. |
| Secondary | Suicidal ideation using the Columbia-Suicide Severity Rating Scale (C-SSRS) score of ≥ 4 | Day 1 - Day 90 | |
| Other | Number of intensive care unit (ICU) stays | Day 1 - Day 90 | |
| Other | Duration of intensive care unit (ICU) stays | Day 1 - Day 90 | |
| Other | Duration (calendar days) of mechanical ventilation | Day 1 - Day 90 | |
| Other | Therapeutic Intensity Scale (TIS) | Day 1 - Day 14 | Assessed on a daily basis until Day 14 post-aSAH for the occurrence or use of mechanical ventilation, ICP monitoring, a central venous or arterial line, an external ventricular drain, deep sedation, pharmacological paralysis, and whether or not the patient is comatose for a period of at least 8 hours on that day. |
| Other | Number of hospital stays | Day 1 - Day 90 | |
| Other | Duration of hospital stays | Day 1 - Day 90 | Calendar days |
| Other | Hospital discharge disposition | Day 1 - Day 90 | Discharge to: (e.g., home, rehabilitation, long-term care) |
| Other | Quality of Life as measured by EQ-5D-3L | Day 30 and Day 90 | |
| Other | Modified Rankin Scale (mRS) | Day 30 and Day 90 | 0 - No symptoms 1. \- No significant disability despite symptoms; able to carry out all usual duties and activities 2. \- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. \- Moderate disability; requiring some help, but able to walk without assistance 4. \- Moderately severe disability; unable to walk and attend to bodily needs without assistance 5. \- Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. \- Dead |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT05995405/registered