Trials / Active Not Recruiting
Active Not RecruitingNCT04057690
Automatic PredICtion of Edema After Stroke
Automatic Prediction of Malignant Brain Edema After Middle Cerebral Artery Ischemic -Stroke
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,687 (actual)
- Sponsor
- University Hospital Tuebingen · Academic / Other
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
To use machine learning for early detection of malignant brain edema in patients with MCA ischemia
Detailed description
Malignant cerebral edema following large ischemic strokes account for up to 10% of all ischemic strokes. Mortality rates are high and most of the survivors are left severely disabled. Although decompressive craniectomy has been shown to significantly decrease mortality, high morbidity rates among survivors are reported. The optimal timepoint when neurosurgical decompression should be performed in the individual patient varies and is a subject of debate. Early prediction of malignant brain edema to identify those patients who benefit from surgical treatment is a clinical challenge. The aim of this study is to use machine learning for comprehensive analysis of CT images as well as clinical data from 1500 patients with large ischemic MCA strokes in oder to develop a model for early prediction of malignant brain edema. In a first step algorithms automatically identify characteristic imaging features and clinical data of 1400 retrospective data sets to create a multistage model (learning phase). This is followed by a validation phase where the model is tested with 100 other retrospective data sets.
Conditions
Timeline
- Start date
- 2019-04-01
- Primary completion
- 2023-09-30
- Completion
- 2025-12-31
- First posted
- 2019-08-15
- Last updated
- 2025-09-10
Locations
19 sites across 3 countries: Austria, Germany, United Kingdom
Source: ClinicalTrials.gov record NCT04057690. Inclusion in this directory is not an endorsement.