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Recruiting NCT06401772

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

No phase Interventional Chronic Subdural Hematoma Recurrence

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intracranial Hypotension Targeted(IHT) Body Posture.
Who it may be relevant to
Registry conditions: Chronic Subdural Hematoma, Recurrence. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Detailed description

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.

Interventions

  • 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

Primary outcome measures

  • subdural hematoma recurrence rate [Time frame: within 90±10 days post-surgery]
Secondary outcome measures (3)
  • change in modified Rankin Scale(mRS) compared to baseline [Time frame: 90±10 days post-surgery]
  • change in EQ-5D-5L score compared to baseline [Time frame: 90±10 days post-surgery]
  • change in MGS-GCS score compared to baseline [Time frame: 90±10 days post-surgery]

Eligibility criteria

Inclusion criteria

  • 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.
  • receive burr hole drainage;
  • sign informed consent voluntarily.

Exclusion criteria

  • 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.
  • 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;
  • CSDH persisting for over 1 year and exhibiting marked organization/solidification of the hematoma;
  • CSDH caused by over V-P shunting;
  • during burr hole drainage, patients have to perform craniotomy due to acute bleeding or brain hernia;
  • Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
  • have deep venous thrombosis of lower extremity or pulmonary embolism;
  • cannot complete regular reexamine within 1 year for any reason;
  • life expectancy less than 1 year;
  • participating other ongoing clinical trial;
  • patients are not qualified for other reason evaluated by two neurosurgeons;
  • have bile reflux gastritis and esophageal diseases.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

China · 1 center
  • Department of Neurosurgery, Huashan Hospital, Fudan University — Shanghai

Identifiers

NCT: NCT06401772 · KY2024-599

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗