Autologous Platelet-rich Plasma Versus Whole Blood for Epidural Patch in Spontaneous Intracranial Hypotension

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBeijing Tiantan Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Informed consent to participate the research obtained from the patient

Satisfies the criteria for SIH according to the International Classification of Headache Disorders.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • PRP Patch group
  • Whole Blood Patch Group

Treatment groups

218 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators