Clinical trial NCT04607447: Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients
Official title: Effectiveness and Safety of Low Intracranial Pressure Treatment Strategies for Patients With Chronic Subdural Hematoma - A Randomized, Controlled, Multi-center Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Subdural Hematoma
Keywords: Low intracranial pressure
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 160
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: subdural hematoma volume
timeFrame: three months
measure: Markwalder scale
timeFrame: three months
measure: Modified Rankin Scale
timeFrame: three months
measure: Extended Glasgow Outcome score
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References: