Phase 2
N=15
A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
Cerebrospinal Fluid Leaks
Bottom Line
View on ClinicalTrials.gov: NCT03276975 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Change in Median (Headache Impact Test-6) HIT-6 Score From Baseline — -12; -7 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- TISSEEL (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Duke University
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Median (Headache Impact Test-6) HIT-6 Score From Baseline |
-12; -7 | — |
| SECONDARY Change in Median HIT-6 Score From Baseline |
-5.5; -7; -4.5; -12 | — |
| SECONDARY Reduction in Median Migraine Disability Assessment (MIDAS) Score From Baseline |
-25; 16; -62.5; -40; -87; -53 | — |
| SECONDARY Change in Median NRS Score From Baseline |
-0.5; -1; -2.5; 0; -1.5; -2 | — |
| SECONDARY Change in Median EQ-5D (European Quality of Life-5 Dimensions) Score From Baseline |
0.1; 0.1; 0; 0.1; 0; 0.2 | — |
| SECONDARY Change in Median WPAI (Work Productivity and Activity Impairment) Score From Baseline |
1.3; -0.3; -13.8; -2.3; -9; -28.5 | — |
| SECONDARY Change in PGIC (Patient Global Impression of Change) Score From Baseline |
3.5; 2; 4; 3; 4.5; 6 | — |
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.
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT03276975). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.