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Current literatures reported that MRM or non-dynamic CTM can not allow for adequate leak localization, so as not to guide targeted epidural patch. Leak detection requires dynamic CTM or DSA, which was not available for all our patients.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blind epidural PRP patch (BEPP) | Experimental | Two-site blind epidural patch with PRP, which was prepared with the 2-stage centrifugation method, at levels C7-T1 and L4-5. |
|
| Targeted epidural PRP patch (TEPP) | Active Comparator | Targeted epidural patch with autologous platelet-rich plasma, which was prepared with the 2-stage centrifugation method. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted epidural PRP patch | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain NRS of orthostatic headache | Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for headache. | 48 hours following epidural patch with PRP |
| Measure | Description | Time Frame |
|---|---|---|
| Pain NRS of orthostatic headache | Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain) for orthostatic headache . | 1, 3 and 6 months following epidural patch with PRP |
| The complete relief rate of epidural patch with PRP |
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Inclusion Criteria:
Exclusion Criteria:
There was concern for other causes of intracranial hypotension, such as postdural puncture, postsurgical and post-traumatic CSF leaks.
Prior treatment with EBP at any time previously.
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.
Unable to comprehend the pain NRS.
Unable to cooperate with postoperative treatment, rehabilitation, and follow-up visits.
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| ID | Term |
|---|---|
| D019585 | Intracranial Hypotension |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
| Blind epidural PRP patch | Procedure | 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. |
|
The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally. |
| 48 hours, 1, 3 and 6 months after the initial targeted or blind patch |
| The good response rate of epidural patch with PRP | Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally. | 48 hours, 1, 3 and 6 months post-procedurally |
| The failure rate of 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 | 48 hours following the initial epidural patch with PRP |
| The recurrence rate in each group. | Recurrence was defined as fresh onset of headaches beyond the 72-hour mark. | During the 6-month follow up |
| Patients' overall satisfaction | Patients' overall satisfaction was graded into very unsatisfactory (1), unsatisfactory (2), neutral (3), satisfactory (4) and very satisfactory (5), according to the Likert scale. | 6 months following the first epidural patch with PRP |
| 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 |