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

Completed · Phase 2

Conditions studied: Cerebrospinal Fluid Leaks

In brief

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 simulated procedure without patching material in patients with spontaneous intracranial hypotension.

Key facts

Study ID

NCT03276975

Run by

Duke University

People needed

15

Starts

2017-12-18

Expected to finish

2020-03-19

Last updated by the study team

2021-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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]

You may not qualify if…

• 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).

Where it is running

• Duke University — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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