Spontaneous Intracranial Hypotension
Conditions
Brief summary
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.
Interventions
PROCEDUREPRP Patch group
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.
PROCEDUREWhole Blood Patch Group
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.
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Informed consent to participate the research obtained from the patient * Satisfies the criteria for SIH according to the International Classification of Headache Disorders.
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 cooperate with postoperative evaluation, treatment, rehabilitation, and follow-up visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The complete relief rate of patients with SIH | At 3 months after first epidural patch | The complete relief was defined as the pain intensity of 0-1/10 on NRS or/and minimal symptoms post-procedurally. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity of orthostatic headache | At 48 hours, 2 weeks, 3 and 6 months after first epidural patch | Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain). |
| The complete relief rate of patients with SIH | At 48 hours, 2 weeks and 6 months after first epidural 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 patients with SIH. | At 48 hours, 2 weeks, 3 and 6 months after first epidural patch | Good response was defined as a headache reduction of at least 50%, with improvement of orthostatic component post-procedurally. |
| The failure rate in each group. | At 6 months after first epidural patch | Failure was defined as a persistent or worsening symptom with less than 50% of headache reduction within 72 hour post-procedurally. |
| The recurrence rate in each group. | At 6 months after first epidural patch | Recurrence was defined as fresh onset of orthostatic headache in completely relieved patients beyond the 72-hour mark. |
| Patients'quality of life | At 3 and 6 months after first epidural patch | 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). |
| Patients' overall satisfaction | At 6 months after first epidural patch | 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 in each group. | 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 | Within 6- month follow up | — |
Outcome results
None listed