spontaneous intracranial hypotension
Conditions
Interventions
Therapy group:Epidural puncture and catheterization, continuous infusion of hydroxyethyl starch injection through an infusion pump for 2-3 days
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18, Diagnosis of spontaneous intracranial hypotension according to the International Classification of Headache Disorders, 3rd edition, ICHD-3: a) Any headache that meets the following criterion c; b) Reduced cerebrospinal fluid (CSF) pressure (<60mmH2O) and/or imaging studies show CSF leakage; c) The onset of headache is temporally related to low CSF pressure or CSF leakage, or the presence of low CSF pressure or CSF leakage is discovered due to headache; if the site of CSF leakage is unknown, perform puncture at the lower thoracic level; d) The patient's presentation cannot be better explained by other disorders in the ICHD-3. 2. Conservative treatment (bed rest, hydration, analgesic treatment, etc.) failed for 2 weeks (clinical symptoms such as postural headache still exist and imaging suggests accumulation of epidural cerebrospinal fluid); 3. Provide patients with detailed information on the advantages, disadvantages, and complications of continuous epidural injection of HES compared to EBP treatment, and obtain informed consent from patients and their families.
Exclusion criteria
Exclusion criteria: 1.The patient refuses to participate in the study; 2.The patient can not cooperate with surgical procedures or there is an infection at the puncture site; 3.Coagulation dysfunction (such as hypocoagulability, thrombocytopenia, or not discontinuing anticoagulant medication, etc.); 4.Hepatic or renal insufficiency, with serum total bilirubin >1.5 times the upper limit of normal (ULN); for patients with liver metastasis >2.5 times ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >2.5 times ULN, or for patients with liver metastasis, ALT and/or AST >5 times ULN, serum creatinine >1.5 times the upper limit of normal (ULN), or creatinine clearance =1 year before screening should also be excluded unless proof can be provided that appropriate treatment has been completed; 10.Clinically significant pleural effusion, pericardial effusion, or ascites requiring multiple drainages within 2 weeks prior to the first administration of the study drug; 11.Known history of human immunodeficiency virus infection; 12.The investigator believes that the subject has any clinical or laboratory abnormalities or compliance issues that make them unsuitable for participation in this clinical study; 13.Presence of severe psychological or mental abnormalities; 14.Any major surgical procedure within <=28 days prior to the first administration of the study drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Success rate for first treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| clinical symptoms;VAS score for positional headache;All related short-term and long-term postoperative complications;The timing of severe headache episodes after standing upright;The duration of time able to stand upright before needing to lie down;The cumulative number of hours able to stand upright each day;Cranial MRI examination;Spinal MRI with water imaging; | — |
Countries
China
Contacts
Public ContactChanghong Miao
Zhongshan Hospital, Fudan University
Outcome results
None listed