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

Fudan University

Status: Unknown

Conditions: Chronic Subdural Hematoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04607447

KY2020-063

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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160 participants in 2 patient groups

Atorvastatin plus Dexamethasone tablets

Active Comparator group

Treatment:

Drug: Atorvastatin plus Dexamethasone

drugs+low intracranial pressure strategy treatment

Experimental group

Description:

Drugs means treatment with Atorvastatin plus Dexamethasone tablets

Treatment:

Behavioral: low intracranial pressure strategy treatment

Drug: Atorvastatin plus Dexamethasone