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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
830
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
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGsubdural 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
Time frame: within 90±10 days post-surgery
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
Time frame: 90±10 days post-surgery
change in EQ-5D-5L score compared to baseline
The 5-level EQ-5D version (EQ-5D-5L) is a standardised measure of health status
Time frame: 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.
Time frame: 90±10 days post-surgery
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