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

• Status: Completed
• Trial end date: 2020-03-19
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Treatments: Fibrin Tissue Adhesive

Criteria

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).