Registry of Chronic Subdural Hematoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorErasmus Medical Center
About this trial
The goal of this observational study is to better understand how chronic subdural hematoma (CSDH) progresses and how patients are treated and cared for. The study focuses on three main questions:
1. What are the characteristics of patients with CSDH when they are diagnosed? 2. What treatments do patients with CSDH receive? 3. What are the outcomes for patients with CSDH, including their functional ability, cognitive health, and neurological status?
Participants will receive their usual standard treatment. As part of the study, they will complete a brief telephone interview three months after their treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with CSDH
18 years or older
Disqualifiers
Patients who do not consent to participate in the registry
Trial population
Patients diagnosed with CSDH will be recruited from participating centers.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,500 Participants
are grouped into 1 trial groupGroup A: CSDH patients
Trial outcomes
Primary outcomes
1
modified Rankin Scale (mRS) score at 3 months following diagnosis
Functional outcome assessed using the modified Rankin Scale (mRS), a 6-point scale where 0 indicates no symptoms, higher scores reflect greater disability, and 6 represents death.
Time frame
3 months following diagnosisSecondary outcomes
1
Recurrence rate within 3 months following diagnosis
Recurrence of symptoms following initial, persistent improvement, confirmed by imaging as CSDH, and potentially requiring reoperation.
Time frame
3 months following diagnosis2
Mortality within 3 months following diagnosis
All-cause mortality.
Time frame
3 months following diagnosis3
Complications within 3 months following diagnosis
Complications after treatment of CSDH.
Time frame
3 months following diagnosis4
Duration of hospital stay
Total number of days admitted to the hospital for CSDH-related causes.
Time frame
3 months following diagnosisSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov