The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorHuashan Hospital
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
chronic subdural hematoma is diagnosed with CT/MRI scan; thickness of hematoma is more than 1 cm;
more than 60 years of age or 60 years;
MGS-GCS (Markwalder's Grading Scale and Glasgow Coma Scale) is less than or equal to 2;
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.
Disqualifiers
have brain hernia or acute massive cerebral infarction that have to perform craniotomy
have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
Trial design
Design model
Parallel
Treatments tested in this trial
Intracranial Hypotension Targeted(IHT) Body Posture
BehavioralIHT 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
Treatment groups
830 Participants
are divided into 2 treatment groupsGroup A: body posture groupExperimental treatment 1 intervention
Group B: control groupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
within 90±10 days post-surgerySecondary outcomes
1
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-surgery2
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-surgery3
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-surgerySponsors and contacts
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Source ClinicalTrials.gov