Clinical trial NCT06401772: The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma
Official title: The Effectiveness and Safety of Body Posture to Improve Intracranial Pressure in Preventing Postoperative Recurrence for Chronic Subdural Hematoma (BP-CSDH) -A Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Subdural Hematoma
Recurrence
Keywords: Chronic Subdural Hematoma
body posture
intracranial pressure
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2024-05-07
Enrollment: 830
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma

Detailed description: This study is a multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment to evaluate the effects of body posture on hematoma recurrence. Patients will be assigned in a 1:1 ratio to body posture group(upper body lay flat, lower body elevate 30° or 20-30cm, head turn to affected side) or control group(supine position) randomly. After operation, patients will be required to keep respective body posture at sleep time for 3 months. Instead of body posture, patients will receive routine treatment.

Eligibility criteria: Inclusion Criteria:

1. chronic hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
2. more than 60 years of age or 60 years;
3. MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
4. patients have neurological symptom caused by CSDH before surgery, such as headache, dizziness, nausea, vomiting, numbness or weakness of limb, instability to walk, unconsciousness, trouble speaking, insensitive, etc.
5. receive burr hole drainage;
6. sign informed consent voluntarily.

Exclusion Criteria:

1. pregnancy or lactation;
2. have hernia of brain or acute massive cerebral infarction that have to perform craniotomy
3. have serous cancer, hemorrhagic disease, cardiac dysfunction and other serious disease that may aggravate patient's condition and impact follow-up;
4. patients can not stay in bed for long-term due to mental illness or spinal disease(kyphotic deformity);
5. CT scan showed that no obvious brain compression or midline shift; no symptom before surgery; neurosurgeon evaluate that patients do not require surgery;
6. have CSDH for more than 1 year or organized hematoma;
7. CSDH caused by over V-P shunting;
8. during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
9. during burr hole drainage, patients have cerebral contusion or drainage catheter insert into brain unexpectedly;
10. have venous thrombosis of lower extremity or pulmonary embolism;
11. cannot regular reexamine within 1 year for any reason;
12. life expectancy less than 1 year;
13. participating other ongoing clinical trial;
14. patients are not qualified for other reason evaluated by two neurosurgeons;
15. have bile reflux gastritis and esophageal diseases.

Primary outcomes:
measure: subdural hematoma recurrence rate
timeFrame: within 90±10 days post-surgery
Secondary outcomes:
measure: change in modified Rankin Scale(mRS) compared to baseline
timeFrame: 90days and 1year post-surgery
measure: change in EQ-5D-5L score compared to baseline
timeFrame: 90days and 1year post-surgery
measure: differences between two group in comorbidities
timeFrame: 90days post-surgery
measure: differences between two group in complications
timeFrame: 90day post-surgery
measure: subdural hematoma recurrence rate
timeFrame: 1year post-surgery
measure: all cause recurrence rate
timeFrame: 90days and 1year post-surgery
measure: differences between two group in recurrence time
timeFrame: within 90days and 1year post-surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurosurgery, Huashan Hospital, Fudan University
state: Shanghai
Study officials:
affiliation: Department of Neurosurgery, Huashan Hospital, Fudan University
name: Xuehai Wu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Neurosurgery, Huashan Hospital, Fudan University
name: ying mao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: