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Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients (CSDH-LP)

Primary Purpose

Chronic Subdural Hematoma

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
low intracranial pressure strategy treatment
Atorvastatin plus Dexamethasone
Sponsored by
Huashan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Subdural Hematoma focused on measuring Low intracranial pressure

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients above 14 yrs with chronic subdural hematoma confirmed by cranial imaging;
  • patients with MGS-GCS score ≤1 point, showing no signs of neurological deficits caused by CSDH or characteristics of high intracranial pressure;
  • patients with MGS-GCS score ≥1 point, but with medication history of anticoagulant or antiplatelet drugs, coagulation dysfunction so that they are unsuitable or intolerant of surgery although they are in stable condition;
  • patients who are unwilling to operate when they have no life-threatening brain herniation or no indications for emergency surgery, which confirmed by two neurosurgeons

Exclusion Criteria:

  • women pregnant or in lactation
  • those who are allergic to atorvastatin, hypoxamethasone;
  • patients with brain herniation or altered mental status;
  • patients with primary diseases like tumors, hemorrhagic diseases or some other critically serious conditions( eg.multiple organ failure);
  • patients with uncontrollable diabetes and heart failure
  • patients with preexisting chronic abdominal diseases (such as inflammatory bowel disease) or lung tumors or digestive system neoplasm
  • Patients with abnormal liver function
  • patients had taken atorvastatin or dexamethasone, ACEI in the past one week
  • other conditions not eligible to enroll the trial confirmed by two individual doctor

Sites / Locations

  • Huashan HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Atorvastatin plus Dexamethasone tablets

drugs+low intracranial pressure strategy treatment

Arm Description

Drugs means treatment with Atorvastatin plus Dexamethasone tablets

Outcomes

Primary Outcome Measures

subdural hematoma volume
difference of hematoma volume in subdura between two groups
Markwalder scale
difference of Markwalder scale between two groups;The Markwalder Scale is designed to measure the chronic subdural hematoma scale. This scale is categorized into four grade. Grade 0 denots the patient neurologically normal, whereas grade 4, the highest grade, denotes the worst neuological assessment.
Modified Rankin Scale
difference of Modified Rankin Scale between two groups; The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.
Extended Glasgow Outcome score
difference of Extended Glasgow Outcome score between two groups; This score is used to measure the outcome after neurological disease. It defines 5 categories of possible outcomes after a brain injury, which is from good recovery(5) to death(1).

Secondary Outcome Measures

Full Information

First Posted
October 26, 2020
Last Updated
November 6, 2020
Sponsor
Huashan Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04607447
Brief Title
Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients
Acronym
CSDH-LP
Official Title
Effectiveness and Safety of Low Intracranial Pressure Treatment Strategies for Patients With Chronic Subdural Hematoma - A Randomized, Controlled, Multi-center Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Recruiting
Study Start Date
August 4, 2020 (Actual)
Primary Completion Date
August 1, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huashan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The proportion of the elderly population is increasing rapidly. Chronic subdural hematoma has become the most common cause of surgery in neurosurgery for elderly patients. The standard treatment for cSDH is mostly surgery. Clinically, we often encounter elderly patients with certain underlying diseases or organ dysfunction, especially preexisting cardiovascular disease or medication history like anticoagulant or antiplatelet drugs, resulting in poor surgical tolerance, high risk during anesthesia and hematoma recurrence. At present, the mechanism of cSDH is not completely clear. Our previous observational studies had shown significant correlation between cSDH and intracranial hypotension. So we would like to conduct a randomized, controlled, multi-center clinical study to explore the effectiveness and safety of low intracranial pressure treatment strategies for patients with chronic subdural hematoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Subdural Hematoma
Keywords
Low intracranial pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin plus Dexamethasone tablets
Arm Type
Active Comparator
Arm Title
drugs+low intracranial pressure strategy treatment
Arm Type
Experimental
Arm Description
Drugs means treatment with Atorvastatin plus Dexamethasone tablets
Intervention Type
Behavioral
Intervention Name(s)
low intracranial pressure strategy treatment
Intervention Description
Supine position for 16h-18h daily, with head toward the affected side in most of the time, and 15-20 cm elevation of lower limbs. Abdominal belt compression
Intervention Type
Drug
Intervention Name(s)
Atorvastatin plus Dexamethasone
Intervention Description
Atorvastatin plus Dexamethasone
Primary Outcome Measure Information:
Title
subdural hematoma volume
Description
difference of hematoma volume in subdura between two groups
Time Frame
three months
Title
Markwalder scale
Description
difference of Markwalder scale between two groups;The Markwalder Scale is designed to measure the chronic subdural hematoma scale. This scale is categorized into four grade. Grade 0 denots the patient neurologically normal, whereas grade 4, the highest grade, denotes the worst neuological assessment.
Time Frame
three months
Title
Modified Rankin Scale
Description
difference of Modified Rankin Scale between two groups; The modified Rankin Scale is a commonly used scale for measuring the degree of disability or dependence in the daily activities of people who have suffered a neurological disability. The scale runs from 0-6, running from perfect health without symptoms to death.
Time Frame
three months
Title
Extended Glasgow Outcome score
Description
difference of Extended Glasgow Outcome score between two groups; This score is used to measure the outcome after neurological disease. It defines 5 categories of possible outcomes after a brain injury, which is from good recovery(5) to death(1).
Time Frame
three months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients above 14 yrs with chronic subdural hematoma confirmed by cranial imaging; patients with MGS-GCS score ≤1 point, showing no signs of neurological deficits caused by CSDH or characteristics of high intracranial pressure; patients with MGS-GCS score ≥1 point, but with medication history of anticoagulant or antiplatelet drugs, coagulation dysfunction so that they are unsuitable or intolerant of surgery although they are in stable condition; patients who are unwilling to operate when they have no life-threatening brain herniation or no indications for emergency surgery, which confirmed by two neurosurgeons Exclusion Criteria: women pregnant or in lactation those who are allergic to atorvastatin, hypoxamethasone; patients with brain herniation or altered mental status; patients with primary diseases like tumors, hemorrhagic diseases or some other critically serious conditions( eg.multiple organ failure); patients with uncontrollable diabetes and heart failure patients with preexisting chronic abdominal diseases (such as inflammatory bowel disease) or lung tumors or digestive system neoplasm Patients with abnormal liver function patients had taken atorvastatin or dexamethasone, ACEI in the past one week other conditions not eligible to enroll the trial confirmed by two individual doctor
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xuehai wu, phD
Phone
8613764880571
Email
wuxuehai2013@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
xiangru Ye, Master
Phone
8618818210651
Email
xiangruye@126.com
Facility Information:
Facility Name
Huashan Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
xuehai wu, PhD
Phone
8613764880571
Email
wuxuehai2013@163.com
First Name & Middle Initial & Last Name & Degree
xiangru ye, Master
Phone
8618818210651
Email
xiangruye@126.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

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