The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma

Recurrence Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06401772
• Other study ID #: KY2024-599
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2024
• Est. completion date: January 2028

Study information

• Verified date: May 2024
• Source: Huashan Hospital
• Contact: Xuehai Wu, Ph.D.
• Phone: +8613764880571
• Email: Wuxuehai2013[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 821
• Est. completion date: January 2028
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Subdural Hematoma
• Hematoma
• Hematoma, Subdural, Chronic
• Recurrence

Intervention

Behavioral:
• body posture
Upper body lay flat, lower body elevate 30° or 20-30cm. As for unilateral CSDH, patients should turn head to the affected side, and turn head up intermittently. It is not allowed to turn head to the contralateral side of hematoma. As for bilateral CSDH, patients can turn head to any side

Locations

Country	Name	City	State
China	Department of Neurosurgery, Huashan Hospital, Fudan University	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 recurrence rate	Recurrence is defined as maximum thickness of subdural hematoma more than 10mm or patients have subdural hematoma related symptom without head injury.	within 90±10 days post-surgery
Secondary	change in modified Rankin Scale(mRS) compared to baseline	The mRS is a clinician-reported measure of global disability,ranging from 0 to 6, with higher scores indicating more severe disability	90days and 1year post-surgery
Secondary	change in EQ-5D-5L score compared to baseline	The 5-level EQ-5D version (EQ-5D-5L) is a standardised measure of health status	90days and 1year post-surgery
Secondary	differences between two group in comorbidities	comparison of comorbidities rate of two group	90days post-surgery
Secondary	differences between two group in complications	comparison of complications rate of two group	90day post-surgery
Secondary	subdural hematoma recurrence rate	comparison of recurrence rate of two group	1year post-surgery
Secondary	all cause recurrence rate	comparison of recurrence rate of two group caused by whatever the reasons	90days and 1year post-surgery
Secondary	differences between two group in recurrence time	comparison of recurrence time of two group	within 90days and 1year post-surgery