Chronic Subdural HematomaNCT06401772
The Effectiveness and Safety of Body Posture in Preventing Postoperative Recurrence for Chronic Subdural Hematoma
A study testing Intracranial Hypotension Targeted(IHT) Body Posture in people with Chronic Subdural Hematoma and Recurrence, run by Huashan Hospital at 1 site in China.
Trial summary
This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Chronic Subdural Hematoma, Recurrence
- What is being tested?
- Intracranial Hypotension Targeted(IHT) Body Posture
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 830 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Neurosurgery, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200000
Xuehai Wu, Ph.D., +8613764880571, Wuxuehai2013@163.com
About this study
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
This study aims to investigate the effectiveness and safety of body posture to improve intracranial pressure in preventing postoperative recurrence for chronic subdural hematoma
Read the 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.
- Conditions
- Chronic Subdural Hematoma, Recurrence
- Being tested
- Intracranial Hypotension Targeted(IHT) Body Posture
- Keywords
- Chronic Subdural Hematoma, body posture, intracranial pressure
- Medical subject headings
- Hematoma, Subdural, Chronic, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracranial Hypotension Targeted(IHT) Body PostureBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| body posture group | Experimental | 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. Receives: Behavioral: Intracranial Hypotension Targeted(IHT) Body Posture |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 90±10 days post-surgery
Secondary outcomes (3)
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
Measured: 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
Measured: 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.
Measured: 90±10 days post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start8 Aug 2024
- Primary completionDec 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Subdural HematomaStudies of the same condition, open and under way.
- More trials run by Huashan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 830 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehai Wu, Huashan Hospital
- Investigators
- Xuehai Wu, Ph.D., Principal investigator, Department of Neurosurgery, Huashan Hospital, Fudan Universityying mao, Ph.D., Principal investigator, Department of Neurosurgery, Huashan Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06401772
- Sponsor's protocol ID
- KY2024-599
- Status last verified
- Apr 2026
- First submitted
- 27 Apr 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06401772
- Acronym / sponsor ID
- KY2024-599
- Conditions
- Chronic Subdural Hematoma, Recurrence
- Keywords
- Chronic Subdural Hematoma, body posture, intracranial pressure
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 830 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 8 Aug 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| body posture group | Experimental | Behavioral: Intracranial Hypotension Targeted(IHT) Body PostureIn-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. |
| 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracranial Hypotension Targeted(IHT) Body PostureIHT 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 | Behavioural | body posture group |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xuehai Wu, Ph.D. principal investigator
Department of Neurosurgery, Huashan Hospital, Fudan University
ying mao, Ph.D. principal investigator
Department of Neurosurgery, Huashan Hospital, Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracranial Hypotension Targeted(IHT) Body Posture in people with Chronic Subdural Hematoma and Recurrence, run by Huashan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xuehai Wu, Ph.D. (+8613764880571, Wuxuehai2013@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
subdural hematoma recurrence rate (time frame: within 90±10 days post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.