Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

  • End date
    Dec 30, 2023
  • participants needed
  • sponsor
    Huashan Hospital
Updated on 26 January 2021


The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.

Condition Chronic subdural hematoma
Treatment low intracranial pressure strategy treatment, Atorvastatin plus Dexamethasone
Clinical Study IdentifierNCT04607447
SponsorHuashan Hospital
Last Modified on26 January 2021


Yes No Not Sure

Inclusion Criteria

patients above 14 yrs with chronic subdural hematoma confirmed by cranial imaging
patients with MGS-GCS score 1 point, showing no signs of neurological deficits caused by CSDH or characteristics of high intracranial pressure
patients with MGS-GCS score 1 point, but with medication history of anticoagulant or antiplatelet drugs, coagulation dysfunction so that they are unsuitable or intolerant of surgery although they are in stable condition
patients who are unwilling to operate when they have no life-threatening brain herniation or no indications for emergency surgery, which confirmed by two neurosurgeons

Exclusion Criteria

women pregnant or in lactation
those who are allergic to atorvastatin, hypoxamethasone
patients with brain herniation or altered mental status
patients with primary diseases like tumors, hemorrhagic diseases or some other critically serious conditions( eg.multiple organ failure)
patients with uncontrollable diabetes and heart failure
patients with preexisting chronic abdominal diseases (such as inflammatory bowel disease) or lung tumors or digestive system neoplasm
Patients with abnormal liver function
patients had taken atorvastatin or dexamethasone, ACEI in the past one week
other conditions not eligible to enroll the trial confirmed by two individual doctor
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