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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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.
• Email: Wuxuehai2013@163.com
• Phone: +8613764880571

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.