Spontaneous intracranial hypotension (SIH) is a condition characterized by refractory orthostatic headache, mostly due to leaks of cerebrospinal fluid (CSF). Epidural patch with autologous platelet-rich plasma (PRP), which contains numerous growth factors and cytokines, has been reported as a new and promising alternative for current standard whole blood patching. However, there is no study comparing the efficacy and safety of the two approaches. In this study, we aimed to provide data concerning the outcomes of PRP patching versus conventional whole blood patching for treatment of refractory SIH cases failing in conservative therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
218
Autologous PRP was prepared with the 2-stage centrifugation method and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The PRP mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively.
Autologous whole blood was prepared and mixed with iohexol contrast. We chose two separate sites for epidural access. A standard epidural puncture was conducted under the guidance of CT. The whole blood mixture was titrated slowly into the epidural space and must be stopped immediately to patient's perception of backache or irradiating pain. A strict bed stay for 48 h was prescribed in supine position postoperatively.
The complete relief rate of patients with SIH
The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally.
Time frame: At 3 months after first epidural patch
Pain intensity of orthostatic headache
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain).
Time frame: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
The complete relief rate of patients with SIH
The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally.
Time frame: At 48 hours, 2 weeks and 6 months after first epidural patch
The good response rate of patients with SIH.
Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally.
Time frame: At 48 hours, 2 weeks, 3 and 6 months after first epidural patch
The failure rate in each group.
Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 72 hour post-procedurally.
Time frame: At 6 months after first epidural patch
The recurrence rate in each group.
Recurrence was defined as fresh onset of orthostatic headache in completely relieved patients beyond the 72-hour mark.
Time frame: At 6 months after first epidural patch
Patients'quality of life
Patients'quality of life was evaluated by Headache Impact Test (HIT-6), with six item scores of headache-related disability divided into 36-49 (little or no impact), 50-55 (some impact), 56-59 (substantial impact), and ≥60 (severe impact).
Time frame: At 3 and 6 months after first epidural patch
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.
Time frame: At 6 months after first epidural patch
The occurrence of complications in each group.
Time frame: During and after first epidural patch until the end of 6-month follow up.
The percent of patients requiring repeat epidural patch in each group
Time frame: Within 6- month follow up
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