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

NCT ID: NCT06401772

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 830 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-08
• Study Completion Date: 2028-01-31

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

Detailed Description

This study is a multicenter prospective randomized clinical trial with open-label treatment and blinded outcome assessment to evaluate the effects of body posture on hematoma recurrence. Patients will be assigned in a 1:1 ratio to body posture group(upper body lay flat, lower body elevate 30° or 20-30cm, head turn to affected side) or control group(supine position) randomly. After operation, patients will be required to keep respective body posture at sleep time for 3 months. Instead of body posture, patients will receive routine treatment.

Conditions

Chronic Subdural Hematoma; Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

body posture group

During post-operative hospitalization, patients will receive routine treatment and keep Intracranial Hypotension Targeted (IHT) Body Posture as long as possible, with the maximum to 14 to 18 hours daily.Body Posture education for patients after discharge, which is keeping IHT Body Posture when on bed rest and sleeping within 3 months as long as possible and recording time every day.Specifically, IHT therapy requires CSDH patients to raise their lower limbs 30° higher over the horizontal level of their head. All leg-lift pads were customized from the same manufacturer and provided to participants by the research group. 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.

Group Type: EXPERIMENTAL

Intracranial Hypotension Targeted(IHT) Body Posture

Intervention Type: 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

control group

Patients will be required to keep supine position. In addition to IHT Body Posture, patients will receive treatment as same as body posture group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. chronic 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. pregnancy or lactation;

2. have hernia of brain or acute massive cerebral infarction that have to perform craniotomy

3. have serous cancer, hemorrhagic disease, cardiac dysfunction and other serious disease that may aggravate patient's condition and impact follow-up;

4. patients can not stay in bed for long-term due to mental illness or spinal disease(kyphotic deformity);

5. CT scan showed that no obvious brain compression or midline shift; no symptom before surgery; neurosurgeon evaluate that patients do not require surgery;

6. have CSDH for more than 1 year or organized 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. during burr hole drainage, patients have cerebral contusion or drainage catheter insert into brain unexpectedly;

10. have venous thrombosis of lower extremity or pulmonary embolism;

11. cannot 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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Huashan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xuehai Wu

Professor, Huashan Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xuehai Wu, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Huashan Hospital, Fudan University

ying mao, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Neurosurgery, Huashan Hospital, Fudan University

Locations

Department of Neurosurgery, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xuehai Wu, Ph.D.

Role: CONTACT

Wuxuehai2013@163.com

+8613764880571

Facility Contacts

Xuehai Wu, Ph.D.

Role: primary

Wuxuehai2013@163.com

+8613764880571

Other Identifiers

KY2024-599

Identifier Type: -

Identifier Source: org_study_id