Low Intracranial Pressure Treatment Strategies for Chronic Subdural Hematoma Patients

NCT04607447 | Unknown DMC

• 1 other identifier: KY2020-063
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Subdural Hematoma

Keywords

Low intracranial pressure

Outcome Measures

Primary Outcomes (4)

• subdural hematoma volume

  difference of hematoma volume in subdura between two groups

  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.

  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.

  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).

  three months

Study Arms (2)

Atorvastatin plus Dexamethasone tablets

ACTIVE COMPARATOR

Drug: Atorvastatin plus Dexamethasone

drugs+low intracranial pressure strategy treatment

EXPERIMENTAL

Drugs means treatment with Atorvastatin plus Dexamethasone tablets

Behavioral: low intracranial pressure strategy treatment; Drug: Atorvastatin plus Dexamethasone

Interventions

low intracranial pressure strategy treatment 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

drugs+low intracranial pressure strategy treatment

Atorvastatin plus Dexamethasone DRUG

Atorvastatin plus Dexamethasone

Atorvastatin plus Dexamethasone tablets; drugs+low intracranial pressure strategy treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huashan Hospital: lead

Study Sites (1)

Huashan Hospital

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

MeSH Terms

Conditions

Hematoma, Subdural, Chronic; Intracranial Hypotension

Interventions

Atorvastatin; Dexamethasone

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)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

xuehai wu, phD

CONTACT

8613764880571; wuxuehai2013@163.com

xiangru Ye, Master

CONTACT

8618818210651; xiangruye@126.com

Study Design

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

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 29, 2020
• Study Start: August 4, 2020
• Primary Completion: August 1, 2023
• Study Completion: December 30, 2023
• Last Updated: November 10, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)