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Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

NCT ID: NCT04607447

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-04

Study Completion Date

2023-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Subdural Hematoma

Keywords

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Low intracranial pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Atorvastatin plus Dexamethasone tablets

Group Type ACTIVE_COMPARATOR

Atorvastatin plus Dexamethasone

Intervention Type DRUG

Atorvastatin plus Dexamethasone

drugs+low intracranial pressure strategy treatment

Drugs means treatment with Atorvastatin plus Dexamethasone tablets

Group Type EXPERIMENTAL

low intracranial pressure strategy treatment

Intervention Type BEHAVIORAL

1. 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

Atorvastatin plus Dexamethasone

Intervention Type DRUG

Atorvastatin plus Dexamethasone

Interventions

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low intracranial pressure strategy treatment

1. 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

Intervention Type BEHAVIORAL

Atorvastatin plus Dexamethasone

Atorvastatin plus Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Huashan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Xuehai Wu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xuehai wu, phD

Role: CONTACT

Phone: 8613764880571

Email: [email protected]

xiangru Ye, Master

Role: CONTACT

Phone: 8618818210651

Email: [email protected]

Facility Contacts

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xuehai wu, PhD

Role: primary

xiangru ye, Master

Role: backup

Other Identifiers

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KY2020-063

Identifier Type: -

Identifier Source: org_study_id