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Clinical Trials in China / NCT06401772
Recruiting Not applicable

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

NCT06401772 · tracked via the Priya Life Science China tracker
Sponsor
Huashan Hospital
Phase
Not applicable
Started
2024-08-08
Last updated
2026-04-30

Condition(s) studied

Chronic Subdural HematomaRecurrence

Investigational drug(s) / intervention(s)

Intracranial Hypotension Targeted(IHT) Body Posture

Intracranial Hypotension Targeted(IHT) Body Posture: IHT therapy requires CSDH patients to raise their lower limbs 30° higher over the horizontal level of their head.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

Study 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

Eligibility

Sex
ALL
Min age
60 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Neurosurgery, Huashan Hospital, Fudan University Shanghai Shanghai Municipality Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06401772 on ClinicalTrials.gov ↗ ← All trials in China