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

April 26, 2026 updated by: Xuehai Wu, Huashan Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

830

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200000
        • Recruiting
        • Department of Neurosurgery, Huashan Hospital, Fudan University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. chronic subdural 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. have brain hernia or acute massive cerebral infarction that have to perform craniotomy
  2. have severe malignancies, hemorrhagic disease, cardiac dysfunction and other serious disease that may impede recovery or follow-up compliance;
  3. Spinal deformities (e.g., kyphosis) or psychiatric disorders precluding prolonged body posture therapy adherence
  4. Concomitant severe intracranial tumors, aneurysms, or vascular malformations that may impede recovery.
  5. 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;
  6. CSDH persisting for over 1 year and exhibiting marked organization/solidification of the 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. Intraoperative complications (e.g., cerebral contusion, intraparenchymal catheter placement) during burr hole drainage;
  10. have deep venous thrombosis of lower extremity or pulmonary embolism;
  11. cannot complete 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: body posture group

In-hospital protocol of Intracranial Hypotension Targeted(IHT) Body Posture

  1. Upper body horizontal and lower limbs elevated 30°, except for postprandial 2 hours to prevent reflux;
  2. For unilateral CSDH: Affected side lateral decubitus combined with intermittent supine positioning; Nonaffected side decubitus should be avoided;
  3. For bilateral CSDH: No specific head position requirements;
  4. Body posture therapy was initiated immediately after randomization and maintained for 14-18 hours daily.
  5. Daily documentation of body posture therapy duration and bed rest time in diary cards.

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.
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
No Intervention: control group
Patients will be required to keep supine position. In addition to body posture therapy, patients will receive treatment as same as body posture group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subdural hematoma recurrence rate
Time Frame: within 90±10 days post-surgery
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in modified Rankin Scale(mRS) compared to baseline
Time Frame: 90±10 days post-surgery
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
Time Frame: 90±10 days post-surgery
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
Time Frame: 90±10 days post-surgery
The MGS-GCS is used to assess the severity of clinical symptoms and consciousness status.
90±10 days post-surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Huashan Hospital

Investigators

  • Principal Investigator: Xuehai Wu, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University
  • Principal Investigator: ying mao, Ph.D., Department of Neurosurgery, Huashan Hospital, Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 8, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2028

Study Registration Dates

First Submitted

April 27, 2024

First Submitted That Met QC Criteria

May 6, 2024

First Posted (Actual)

May 7, 2024

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2024-599

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Recurrence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Argentina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe