CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
TISSEELdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03276975
NCT03276975Phase 2Completed
CompareCT.gov

A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment of Cerebrospinal Fluid Leaks in Spontaneous Intracranial Hypotension.

Duke University·interventional·Posted Sep 8, 2017·Updated Jun 18, 2021

In Brief

A Phase 2 clinical trial evaluating TISSEEL for Cerebrospinal Fluid Leaks. Completed, enrolled 15 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebrospinal Fluid Leaks
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedSep 8, 2017
Enrollment StartDec 18, 2017
Primary CompletionMar 19, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 8.8 years ago

Interventions

TISSEELdrug

TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (\>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients