Trial · NCT01454154
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from Baseline in Edema | Baseline, Day 3, Day 90, and Day 180 | To be assessed using Magnetic Resonance Imaging (MRI). |
| Primary | Change from Baseline in Hemorrhage | Baseline, Day 3, Day 90, and Day 180 | To be assessed using MRI. |
| Primary | Number of Participants with Adverse Events and Serious Adverse Events | Up to 180 Days | An adverse event (AE) is any symptom, sign, illness or experience that develops or worsens in severity during the course of the study. A serious adverse event is any AE that is fatal, life-threatening, requires or prolongs hospital stay, results in persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event |
| Secondary | Change from Baseline in Brain Volume | Baseline, Day 3, Day 90, and Day 180 | To be assessed using MRI. |
| Secondary | Number of Participants with Abnormalities Associated with Brain Swelling | Baseline, Day 3, Day 90, and Day 180 | To be assessed using MRI and computed tomography (CT). |
| Secondary | Change from Baseline in Glasgow Coma Scale (GCS) | Baseline up to Day 7 | The GCS is scored between 3 and 15 (3 = the worst, and 15 = best). It is composed of three parameters : Best Eye Response (scored on a scale of 1-4), Best Verbal Response (scored on a scale of 1-5), Best Motor Response (scored on a scale of 1-6) |
| Secondary | Change from Baseline in Intracranial Pressure (ICP) | Baseline up to Day 7 | |
| Secondary | Change from Day 30 in Extended Glasgow Outcome Scale (GOS-E) | Day 30, Day 60, Day 90, and Day 180 | The GOS-E assesses status in patients with traumatic brain injury on an 8-point scale. The minimum score is 1 and the maximum score is 8. The rating scale is as follows: 1- Dead, 2- Vegetative State, 3- Low Severe Disability, 4- Upper Severe Disability, 5- Low Moderate Disability, 6- Upper Moderate Disability, 7- Low Good Recovery, and 8- Upper Good Recovery |
| Secondary | Number of Participants Requiring Decompression Craniectomy | Baseline up to Day 7 | |
| Secondary | Number of Participants Experiencing Neuroworsening | Baseline up to Day 7 | |
| Secondary | PK Parameter: Steady State Concentration of Glyburide | Baseline and 36 hours | |
| Secondary | Number of All-Cause and Neurological Mortalities | Up to Day 180 |
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/NCT01454154/registered