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

Not Applicable

Recruiting

• Conditions: Chronic Subdural Hematoma; Recurrence
• Interventions: Behavioral: Intracranial Hypotension Targeted(IHT) Body Posture

• Registration Number: NCT06401772
• Lead Sponsor: Huashan Hospital

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.

Study Timeline

• Study First Submitted: 2024-04-27
• Study First Submitted QC: 2024-05-06
• Study First Posted: 2024-05-07
• Study Start: 2024-08-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-15
• Last Update Posted: 2024-11-19
• Primary Completion: 2026-12
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 830

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
body posture group	Intracranial Hypotension Targeted(IHT) Body Posture	During post-operative hospitalization, patients will receive routine treatment and keep Intracranial Hypotension Targeted (IHT) Body Posture as long as possible, with the maximum to 14 to 18 hours daily.Body Posture education for patients after discharge, which is keeping IHT Body Posture when on bed rest and sleeping within 3 months as long as possible and recording time every day.Specifically, IHT therapy requires CSDH patients to raise their lower limbs 30° higher over the horizontal level of their head. All leg-lift pads were customized from the same manufacturer and provided to participants by the research group. For patients with unilateral CSDH, the head should be tilted towards the hematoma affected side and opposite side lying should be avoided as much as possible. For patients with bilateral CSDH, there is no need for the head lateralization. To avoid food reflux and aspiration pneumonia, IHT therapy was strictly prohibited within 2 hours after each meal.

Primary Outcome Measures

Name	Time	Method
subdural hematoma recurrence rate	within 90±10 days post-surgery	Recurrence is defined as maximum thickness of subdural hematoma more than 10mm, and patients have subdural hematoma related symptoms without head injury.

Secondary Outcome Measures

Name	Time	Method
change in EQ-5D-5L score compared to baseline	90days and 1year post-surgery	The 5-level EQ-5D version (EQ-5D-5L) is a standardised measure of health status
differences between two group in comorbidities	90days post-surgery	comparison of comorbidities rate of two group
subdural hematoma recurrence rate	1year post-surgery	comparison of recurrence rate of two group
change in modified Rankin Scale(mRS) compared to baseline	90days and 1year post-surgery	The mRS is a clinician-reported measure of global disability,ranging from 0 to 6, with higher scores indicating more severe disability
differences between two group in complications	90day post-surgery	comparison of complications rate of two group
differences between two group in recurrence time	within 90days and 1year post-surgery	comparison of recurrence time of two group
all cause recurrence rate	90days and 1year post-surgery	comparison of recurrence rate of two group caused by whatever the reasons

Trial Locations

Locations (1)

Department of Neurosurgery, Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China