Chronic Subdural HematomaCSDH-LPNCT04607447
Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients
A study testing low intracranial pressure strategy treatment and Atorvastatin plus Dexamethasone in people with Chronic Subdural Hematoma, run by Huashan Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Chronic Subdural Hematoma
- What is being tested?
- low intracranial pressure strategy treatment and Atorvastatin plus Dexamethasone
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 4 Aug 2020to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huashan Hospital
Shanghai, Shanghai Municipality, 200040
xuehai wu, PhD, 8613764880571, wuxuehai2013@163.com
xiangru ye, Master, 8618818210651, xiangruye@126.com
About this study
Official title: Effectiveness and Safety of Low Intracranial Pressure Treatment Strategies for Patients With Chronic Subdural Hematoma - A Randomized, Controlled, Multi-center Clinical Study
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.
- Conditions
- Chronic Subdural Hematoma
- Being tested
- low intracranial pressure strategy treatment, Atorvastatin plus Dexamethasone
- Keywords
- Low intracranial pressure
- Medical subject headings
- Hematoma, Subdural, Chronic, Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low intracranial pressure strategy treatmentBehavioural
- 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
Atorvastatin plus DexamethasoneDrug
Atorvastatin plus Dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Atorvastatin plus Dexamethasone tablets | Active comparator | Not described Receives: Drug: Atorvastatin plus Dexamethasone |
| drugs+low intracranial pressure strategy treatment | Experimental | Drugs means treatment with Atorvastatin plus Dexamethasone tablets Receives: Behavioral: low intracranial pressure strategy treatment; Drug: Atorvastatin plus Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
subdural hematoma volume
difference of hematoma volume in subdura between two groups
Measured: three months
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.
Measured: three months
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.
Measured: three months
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).
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2020
- Study start4 Aug 2020
- Primary completion1 Aug 2023 (estimated)
- Study completion30 Dec 2023 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huashan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xuehai Wu, Huashan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04607447
- Sponsor's protocol ID
- KY2020-063
- Acronym
- CSDH-LP
- Status last verified
- Nov 2020
- First submitted
- 26 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Low Intracranial Pressure Treatment Strategies for Patients With Chronic Subdural Hematoma - A Randomized, Controlled, Multi-center Clinical Study
- ClinicalTrials.gov ID
- NCT04607447
- Acronym / sponsor ID
- CSDH-LP / KY2020-063
- Conditions
- Chronic Subdural Hematoma
- Keywords
- Low intracranial pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Huashan HospitalUniversity, hospital or other
- Study start
- 4 Aug 2020 (actual)
- Primary completion
- 1 Aug 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 29 Oct 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atorvastatin plus Dexamethasone tablets | Active comparator | Drug: Atorvastatin plus Dexamethasone |
| drugs+low intracranial pressure strategy treatment | Experimental | Behavioral: low intracranial pressure strategy treatment, Drug: Atorvastatin plus DexamethasoneDrugs means treatment with Atorvastatin plus Dexamethasone tablets |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| low intracranial pressure strategy treatment1. 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. 2. Abdominal belt compression | Behavioural | drugs+low intracranial pressure strategy treatment |
| Atorvastatin plus DexamethasoneAtorvastatin plus Dexamethasone | Drug | Atorvastatin plus Dexamethasone tablets, drugs+low intracranial pressure strategy treatment |
Primary outcome
subdural hematoma volume
Time frame: three months
difference of hematoma volume in subdura between two groups
Markwalder scale
Time frame: three months
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
Time frame: three months
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
Time frame: three months
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low intracranial pressure strategy treatment and Atorvastatin plus Dexamethasone in people with Chronic Subdural Hematoma, 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 10 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xuehai wu, phD (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 volume (time frame: three months). The study lists 4 primary outcomes in all. 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 10 Nov 2020.