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.
Informed consent to participate the research obtained from the patient
Satisfies the criteria for SIH according to the International Classification of Headache Disorders.
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
Parallel
PRP Patch group
Procedure/SurgeryAutologous 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.
Whole Blood Patch Group
Procedure/SurgeryAutologous 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.
Pain intensity of orthostatic headache
Pain intensity was evaluated by pain numeric rating scale (NRS; 0 = no pain, 10 = unbearable pain).
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.
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.
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.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
