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

NCT06401772 | Recruiting

• 1 other identifier: KY2024-599
• Study Type: interventional
• Target: 830
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Chronic Subdural Hematoma; Recurrence

Keywords

Chronic Subdural Hematoma; body posture; intracranial pressure

Outcome Measures

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

  within 90±10 days post-surgery

Secondary Outcomes (3)

• change in modified Rankin Scale(mRS) compared to baseline

  90±10 days post-surgery

• change in EQ-5D-5L score compared to baseline

  90±10 days post-surgery

• change in MGS-GCS score compared to baseline

  90±10 days post-surgery

Study Arms (2)

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.

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.

Interventions

Intracranial Hypotension Targeted(IHT) Body Posture BEHAVIORAL

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

body posture group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Recurrence

Interventions

Posture

Condition Hierarchy (Ancestors)

Hematoma, Subdural; Intracranial Hemorrhage, Traumatic; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hematoma; Hemorrhage; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Xuehai Wu, Ph.D.

  Department of Neurosurgery, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

• ying mao, Ph.D.

  Department of Neurosurgery, Huashan Hospital, Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xuehai Wu, Ph.D.

CONTACT

+8613764880571; Wuxuehai2013@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Huashan Hospital

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: May 7, 2024
• Study Start: August 8, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)