The PATCH Trial – Duke CSF Leak Team

The PATCH Trial – Duke CSF Leak Team


[MUSIC] I’m Tim Amrhein, I’m a neuroradiologist
here at Duke University Medical Center. And I specialize in spine intervention,
and in particular, in the treatment of patients with CSF
leaks and CSF pressure pathologies, and spontaneous intracranial hypotension. [MUSIC] Patients with spontaneous
intracranial hypotension or CSF leaks present with a whole
bunch of different symptoms. Most commonly they present with
orthostatic headaches which are headaches that are better when laying down and
worse when standing up. In addition to this though, they can have
a bunch of different, other symptoms, that are related to the cranial nerves,
which includes double vision, loss of vision, loss of hearing,
ringing in the ears, changes in taste. Sometimes dysautonomias, where there’s
changes in heart rate or blood pressure. And because of this it’s a really
difficult diagnosis to make and one that’s often missed. These patients often suffer considerably
secondary to their symptoms. But there is a treatment,
and that’s blood patching. Since spontaneous intracranial hypotension
is such an underdiagnosed condition and poorly known about,
a lot of research still needs to be done. And in particular we need more research
on how to diagnose the condition, find the causative to venus fistulas, and CSF
leaks that we know cause the condition, and learn better how to
treat these patients. [MUSIC] Part of our research efforts here at
Duke include the initiation of the first ever prospective randomized clinical
trial examining the efficacy of targeted blood and fiber glue patching. This is the patch trial. The patch trial is designed such that we
take patients who have known spontaneous intracranial hypotension, and importantly,
a defined and clear CSF leak on imaging. Such as a CT myelogram, and we randomize
them into one of two treatment arms. One treatment arm the patients receive
the optimal therapy that we have today. CT fluoroscopy headed patching
with both blood and fibrin glue. In the other treatment arm the patients
receive a simulated procedure. This is a really important trial because
the goal of course is to prove that patching works. And to confirm that this is
the best course of action for patients with this condition around
the country and around the world. [MUSIC] For this first critically important trial,
we need to enroll patients who have a confirmed and definite CSF leak
that we can see on spinal imaging. So unfortunately, this doesn’t include
patients where we suspect that they have a CSF leak on imaging, or even patients that we know have
spontaneous intracranial hypotension. But we can’t find the CSF leak. We first need to confirm that
patching works by examining patients where we can definitively
find the source of the leak. This trial will form the basis for even bigger trials in the future where we
examine some other important questions as to whether or not targeted patching
versus non targeting patching is optimal. And even whether or
not the additional fiber and glue is helpful in treating
patients with CSF leaks. [MUSIC]

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