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This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma
The BP-CSDH study is a prospective, multicentre, open-label, randomised controlled trial with blinded endpoint assessment. 830 eligible patients will be randomised 1:1 to body posture therapy group or the control group. Follow-up assessments will be conducted at 30 days (±7 days), 90 days (±10 days) and 365 days(±30 days) post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| body posture group | Experimental | In-hospital protocol of Intracranial Hypotension Targeted(IHT) Body Posture
Post-discharge: patients received stage-stratified body posture therapy education Month 1: Perform body posture therapy during bed rest, minimum 6 hours daily. Months 2-3: Based on 1 month CT/MRI:(1) Complete/near-complete hematoma resolution: Continue therapy ≥1 hour/day. (2) Persistent significant subdural hematoma: Maintain therapy≥6 hours/day until Month 3. |
|
| control group | No Intervention | Patients will be required to keep supine position. In addition to body posture therapy, patients will receive treatment as same as body posture group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intracranial Hypotension Targeted(IHT) Body Posture | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| subdural hematoma recurrence rate | Hematoma recurrence was defined as the presence of symptoms attributable to subdural hematoma after surgery, accompanied by a maximum hematoma thickness exceeding 10 mm on imaging, excluding hemorrhage caused by new head trauma | within 90±10 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| change in modified Rankin Scale(mRS) compared to baseline | The mRS is a clinician-reported measure of global disability,ranging from 0 to 6, with higher scores indicating more severe disability | 90±10 days post-surgery |
| change in EQ-5D-5L score compared to baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xuehai Wu, Ph.D. | Contact | +8613764880571 | Wuxuehai2013@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xuehai Wu, Ph.D. | Department of Neurosurgery, Huashan Hospital, Fudan University | Principal Investigator |
| ying mao, Ph.D. | Department of Neurosurgery, Huashan Hospital, Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurosurgery, Huashan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
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| ID | Term |
|---|---|
| D020200 | Hematoma, Subdural, Chronic |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D006408 | Hematoma, Subdural |
| D020198 | Intracranial Hemorrhage, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
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| ID | Term |
|---|---|
| D011187 | Posture |
| ID | Term |
|---|---|
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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The 5-level EQ-5D version (EQ-5D-5L) is a standardised measure of health status |
| 90±10 days post-surgery |
| change in MGS-GCS score compared to baseline | The MGS-GCS is used to assess the severity of clinical symptoms and consciousness status. | 90±10 days post-surgery |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006406 | Hematoma |
| D006470 | Hemorrhage |
| D014947 | Wounds and Injuries |