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

Phase 2

Waitlist Available

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

* 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 \[25\]

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 weeks, 1 month, 4 months

Awards & highlights

All Individual Drugs Already Approved

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.

Eligible Conditions

CSF leak

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 weeks, 1 month, 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 weeks, 1 month, 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 weeks, 1 month, 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Median (Headache Impact Test-6) HIT-6 Score From Baseline

Secondary study objectives

Change in Median EQ-5D (European Quality of Life-5 Dimensions) Score From Baseline

Change in Median HIT-6 Score From Baseline

Change in Median NRS Score From Baseline

+3 more

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Patching of CSF Leaks with Autologous Blood and FibrinActive Control1 Intervention

CT fluoroscopy-guided blood and fibrin glue patching targeted to the site of CSF leak.

Group II: Simulated Patching ProcedurePlacebo Group1 Intervention

Instead of injection of blood and fibrin glue patching material through the needles, an equivalent volume of preservative free sterile Elliots B solution will be injected.

0 / 1Eligibility criteria met