Using body posture to prevent recurrence of chronic subdural hematoma after surgery

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

This study is testing if certain sleeping positions can help prevent chronic subdural hematomas from coming back after surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 830 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Huashan Hospital (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06401772 on ClinicalTrials.gov

What this trial studies

This multicenter prospective randomized clinical trial investigates the effectiveness and safety of specific body postures in preventing the recurrence of chronic subdural hematoma after surgical intervention. Patients will be randomly assigned to either a body posture group, where they will maintain a specific position during sleep, or a control group that will follow standard postoperative care. The study aims to assess the impact of these postures on intracranial pressure and hematoma recurrence over a three-month period. Outcome assessments will be conducted in a blinded manner to ensure objectivity.

Who should consider this trial

Good fit: Ideal candidates are patients over 60 years old diagnosed with chronic subdural hematoma requiring burr hole drainage.

Not a fit: Patients with serious comorbidities or those unable to maintain bed rest due to mental or spinal conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of postoperative recurrence of chronic subdural hematoma in elderly patients.

How similar studies have performed: While the specific approach of using body posture is novel, similar studies on postoperative care have shown varying degrees of success in reducing complications.

Eligibility criteria

Inclusion Criteria:

1. chronic subdural 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. have brain hernia or acute massive cerebral infarction that have to perform craniotomy
2. have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
3. Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
4. Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
5. Patients with cranial CT demonstrating no significant compression or displacement of brain tissue, asymptomatic presentation, and unaffected daily activities were deemed ineligible for surgical intervention by neurosurgeons;
6. CSDH persisting for over 1 year and exhibiting marked organization/solidification of the 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. Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
10. have deep venous thrombosis of lower extremity or pulmonary embolism;
11. cannot complete 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Department of Neurosurgery, Huashan Hospital, Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Xuehai Wu, Ph.D. — Department of Neurosurgery, Huashan Hospital, Fudan University
• Study coordinator: Xuehai Wu, Ph.D.

Conditions: Chronic Subdural Hematoma, Recurrence, body posture, intracranial pressure