A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment

Spontaneous intracranial hypotension (SIH) is a condition caused by non-iatrogenic spinal CSF
leaks that classically presents with orthostatic headaches. These headaches, in conjunction
with other presenting symptoms such as nausea, diplopia, tinnitus, and cognitive deficits,
often result in profound disability. SIH is considerably underreported due to pervasive
misdiagnosis. Thus, while the estimated annual incidence is reported to be 5 in 100,000, the
actual number is likely considerably greater.

The current standard-of-care treatment for SIH cases that are refractory to conservative
measures (i.e. bed rest and hydration) is percutaneous epidural blood patching (EBP) of the
spinal CSF leak. Percutaneous EBP can be performed in several ways: 1) with or without
imaging guidance, 2) targeted to a site of known or suspected CSF leak or non-targeted, and
3) with or without the addition of fibrin glue sealant.

The leading theory for the mechanism behind percutaneous EBP treatment of SIH is that it
creates a durable seal of the CSF leak resulting in normalization of CSF hydrodynamics and a
resultant diminution in symptoms. Fibrin glue, a sealant used for treatment of unintended
durotomies during neurosurgery, is thought to improve the likelihood of a successful patch
over patches containing blood alone. Therefore, imaging-guided targeted delivery of patching
material containing both blood and fibrin glue directly to the site of CSF leak, a novel
therapy, is presumed to be the optimal therapy. For this reason, this procedure has become
standard-of-care at many tertiary-care institutions over the past several years.

Our group has extensive experience with CT fluoroscopy-guided targeted blood and fibrin glue
patching of proven CSF leaks in SIH patients. However, significant uncertainty remains with
regard to the efficacy of this procedure due to a paucity of outcomes data and the absence of
any prospective RCTs. In fact, nearly all of the current evidence for the treatment of SIH is
found in the form of retrospective chart reviews. Given the growing recognition of SIH, the
fact that a known subset of patients will have spontaneous resolution of symptoms, and the
absence of clear evidence to guide treatment, there is a critical need to evaluate the
efficacy of targeted patching with blood and fibrin glue with a prospective RCT. Fulfilling
this unmet need forms the basis for this proposal. While determining the efficacy of the
other types of EBPs is also important, we aim to begin by evaluating the efficacy of the
presumed optimal therapy.

Inclusion Criteria:

- Adult patients meeting International Classification of Headache Disorders 3rd Edition
(ICHD-3) criteria for a diagnosis of SIH (Table 1) who have had a contrast-enhanced
brain MRI and a myelogram confirming the presence of a CSF leak will be recruited from
the Duke Radiology spine intervention clinic [25]

Exclusion Criteria:

- recent (i.e., < 2 weeks) blood patch

- contraindication or inability to undergo the procedure

- inability to provide informed consent

- expected inability to complete follow-up assessment

- a contraindication to receiving contrast material (precluding an epidurogram)

- contraindication to receiving fibrin glue (i.e., allergy).