Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT04203550
Eligibility Criteria:
Inclusion Criteria:
* Patients with a symptomatic unilateral or bilateral CSDH requiring burr-hole evacuation
o Predominantly hypodense or isodense on imaging (CT/MRI).
* Clinical symptoms correlating with the CSDH
* Patients with bilaterally operated CSDHs will be treated with the same protocol on both sides and analyzed as a single study participant
Exclusion Criteria:
* CSDH requiring surgical treatment other that burr-hole evacuation (e.g. craniotomy)
* CSDH in a patient who has a cerebrospinal fluid shunt
* Patients who have undergone any intracranial surgery before
* Comatose patients (GCS 8 or lower) with absent motor responses to painful stimuli; decerebrate or decorticate posturing
* Patient's postoperative cooperation is suspected to be insufficient for drain usage, i.e. disoriented or semiconscious patient
* Patient has a hematogenic malignancy that has obtained active treatment within the previous five years
* Patient has a central nervous system tumor or malignancy
* Patient has acute infection with fever and requires antibiotic treatment at the moment
* Patient has a high risk of life-threatening thrombosis (e.g. recent coronary stent, recent pulmonary embolism, low cardiac valve replacement) and discontinuation of antithrombotic medication is not recommended
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04203550
Study Brief:
Protocol Section:
NCT04203550