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RECRUITINGINTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form voluntarily. Who Should NOT Join This Trial: 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

BEHAVIORAL

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

Locations (1)

Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China