Status:
COMPLETED
A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
Lead Sponsor:
Duke University
Conditions:
Cerebrospinal Fluid Leaks
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this randomized controlled trial (RCT) is to compare the efficacy of CT fluoroscopy-guided targeted epidural patching for treatment of imaging-confirmed spinal CSF leaks to that of a simul...
Detailed Description
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 pre...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 19 2020
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03276975
Start Date
December 18 2017
End Date
March 19 2020
Last Update
June 18 2021
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710