Trial · NCT02568124
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Hematoma resolution | 20 weeks | The rate of chronic subdural hematoma resolution without intervening unplanned surgical procedure. Specifically, if the initial management strategy chosen by the attending physician within the first 24 hours of presentation consists of expectant management, any surgical procedure leads to a failure of meeting the primary outcome. On the other hand, if the management strategy chosen by the attending physician within the first 24 hours of presentation included a surgical evacuation of the CSDH, the primary outcome is met if the control CT scan at 20 weeks demonstrates a complete radiological resolution of the CSDH. Should a second surgery be required, the subject will fail to meet the primary outcome even if the CSDH has completely resolved by 20 weeks. |
| Secondary | Hematoma volume | 20 weeks | Measured by segmentation analysis on the 20 weeks CT scan |
| Secondary | Surgical evacuation | 32 weeks | The incidence of surgical evacuation procedures |
| Secondary | Hematoma recurrence | 32 weeks | |
| Secondary | Cognitive function | 10 weeks | Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE) |
| Secondary | Cognitive function | 32 weeks | Assessed by the Montreal Cognitive Assessment (MoCA) and Mini-Mental State Examination (MMSE) |
| Secondary | Functional autonomy | 10 weeks | Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE) |
| Secondary | Functional autonomy | 32 weeks | Assessed by the modified Barthel Index (mBI) and Glasgow Outcome Scale Extended (GOSE) |
| Secondary | Quality of life scores at 10 weeks | 10 weeks | Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS) |
| Secondary | Quality of life scores at 32 weeks | 32 weeks | Assessed by the EQ-5D-5L and the Sherbrooke Neuro-oncology Assessment Scale (SNAS) |
| Secondary | Length initial of hospital stay | 32 weeks | |
| Secondary | Number of rehospitalisation | 32 weeks | |
| Secondary | Complications | 32 weeks | Incidence of any complication related to tranexamic acid administration |
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
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GET https://conductscience.org/api/trials/v1/NCT02568124/registered