Spontaneous Intracranial Hypotension
Conditions
Brief summary
Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to loss of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a successful alternative for whole blood in dura repair. However, there is no report regarding the best approach to use: targeted epidural PRP patch (TEPP) versus blind epidural PRP patch (BEPP). Preliminary work has suggested that both targeted and blind approaches are effective when using whole blood for epidural patch. Furthermore, two-site blind approach could be considered as a viable initial treatment regardless of the identification of the leak for conventional targeted approach. In this study, the investigators aimed to investigate the non-inferiority of two-site BEPP compared with TEPP for the treatment of refractory SIH cases failing in conservative therapy.
Interventions
PROCEDURETargeted epidural PRP patch
Each patient was subjected to either magnetic resonance myelography (MRM) or/and computed tomography myelography (CTM) to detect the location of CSF leaking. PRP was prepared with the 2-stage centrifugation method and a standard epidural puncture was conducted at the definitive CSF leak locations under the guidance of CT. A predetermined volume of PRP (no more than 10 mL) was titrated slowly into the epidural space for each level. A strict bed stay for 48 h was prescribed in supine position postoperatively.
PROCEDUREBlind epidural PRP patch
PRP was prepared with the 2-stage centrifugation method and the investigators chose two separate sites for epidural access, the C7-T1 and L4-5 levels. A standard epidural puncture was conducted under the guidance of CT. A predetermined volume of PRP (no more than 10 mL) was titrated slowly into the epidural space for each level. A strict bed stay for 48 h was prescribed in supine position postoperatively.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Informed consent to participate the research obtained from the patient. 2. Age 18-65 years. 3. Satisfies the criteria for SIH according to the International Classification of Headache Disorders criteria for headaches attributed to spontaneous (or idiopathic) low CSF pressure. 4. Failed conservative management (bed rest oral or intravenous hydration, and analgesics) lasting at least 2 weeks.
Exclusion criteria
1. There was concern for other causes of intracranial hypotension, such as postdural puncture, postsurgical and post-traumatic CSF leaks. 2. Prior treatment with EBP at any time previously. 3. Any contraindication to epidural puncture, such as space-occupying intracranial or intraspinal lesions, spinal defect, suspected infection over the puncture site, bleeding disorder and current anticoagulation therapy. History of drug and alcohol abuse, cognitive dysfunction, or mental illness. 4. Unable to comprehend the pain NRS. 5. Unable to cooperate with postoperative treatment, rehabilitation, and follow-up visits.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain NRS of orthostatic headache | 48 hours following epidural patch with PRP | Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for headache. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain NRS of orthostatic headache | 1, 3 and 6 months following epidural patch with PRP | Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for orthostatic headache . |
| The complete relief rate of epidural patch with PRP | 48 hours, 1, 3 and 6 months after the initial targeted or blind patch | The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally. |
| The good response rate of epidural patch with PRP | 48 hours, 1, 3 and 6 months post-procedurally | Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally. |
| The failure rate of epidural patch with PRP | 48 hours following the initial epidural patch with PRP | Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 48 hours following the initial epidural patch with PRP |
| The recurrence rate in each group. | During the 6-month follow up | Recurrence was defined as fresh onset of headaches beyond the 72-hour mark. |
| Patients' overall satisfaction | 6 months following the first epidural patch with PRP | Patients' overall satisfaction was graded into very unsatisfactory (1), unsatisfactory (2), neutral (3), satisfactory (4) and very satisfactory (5), according to the Likert scale. |
| The occurrence of complications | During and after the epidural patch with PRP until the end of 6-month follow up | — |
| The percent of patients requiring repeat epidural PRP patch | During the 6- month follow up | — |
Outcome results
None listed