Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

Chronic Subdural Hematoma Clinical Trial

— CSDH-LP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04607447
• Other study ID #: KY2020-063
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2020
• Source: Huashan Hospital
• Contact: xuehai wu, phD
• Phone: 8613764880571
• Email: wuxuehai2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 30, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic
• Intracranial Hypotension

Intervention

Behavioral:
• low intracranial pressure strategy treatment
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

Drug:
• Atorvastatin plus Dexamethasone
Atorvastatin plus Dexamethasone

Locations

Country	Name	City	State
China	Huashan Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Huashan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	subdural hematoma volume	difference of hematoma volume in subdura between two groups	three months
Primary	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
Primary	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
Primary	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