Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

Study Overview
=================
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.

Official Title
-----------------
Effectiveness and Safety of Low Intracranial Pressure Treatment Strategies for Patients With Chronic Subdural Hematoma - A Randomized, Controlled, Multi-center Clinical Study

Conditions
-----------------
Chronic Subdural Hematoma

Intervention / Treatment
-----------------
* Behavioral: low intracranial pressure strategy treatment
* Drug: Atorvastatin plus Dexamethasone


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin plus Dexamethasone tablets<br> | Drug: Atorvastatin plus Dexamethasone<br>* Atorvastatin plus Dexamethasone<br>|
| Experimental: drugs+low intracranial pressure strategy treatment<br>Drugs means treatment with Atorvastatin plus Dexamethasone tablets | Behavioral: low intracranial pressure strategy treatment<br>* Supine position for 16h-18h daily, with head toward the affected side in most of the time, and 15-20 cm elevation of lower limbs. Abdominal belt compression<br>Drug: Atorvastatin plus Dexamethasone<br>* Atorvastatin plus Dexamethasone<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| subdural hematoma volume | difference of hematoma volume in subdura between two groups | three months | 
| Markwalder scale | difference of Markwalder scale between two groups;The Markwalder Scale is designed to measure the chronic subdural hematoma scale. This scale is categorized into four grade. Grade 0 denots the patient neurologically normal, whereas grade 4, the highest grade, denotes the worst neuological assessment. | three months | 
| Modified Rankin Scale | difference of Modified Rankin Scale between two groups; The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death. | three months | 
| Extended Glasgow Outcome score | difference of Extended Glasgow Outcome score between two groups; This score is used to measure the outcome after neurological disease. It defines 5 categories of possible outcomes after a brain injury, which is from good recovery(5) to death(1). | three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Low intracranial pressure