drugset / Trial / NCT03276975

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

NCT03276975

Phase 2 Completed 15 enrolled Duke University
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2017-12-18
Primary completion
2020-03-19
Completion
2020-03-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fibrinogen Concentrate Human Protein / enzyme biologic