CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
CSFD and elevation of MAP +1 moreprocedure
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/NCT02495545
NCT02495545N/ACompleted
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A Multi-Center, Randomized, Controlled, Trial of Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury

St. Joseph's Hospital and Medical Center, Phoenix·interventional·Posted Jul 13, 2015·Updated Nov 27, 2019

In Brief

A clinical study evaluating CSFD and elevation of MAP and Maintenance of MAP for Spinal Cord Injury. Completed, enrolled 15 participants across 3 sites.

Detailed Summary

The purpose of this Phase IIB randomized controlled trial is to evaluate the safety and efficacy of CSFD and to provide a preliminary clinical efficacy evaluation of the combination of CSFD and elevation of mean arterial pressure (MAP) in patients with acute spinal cord injury (SCI). The objectives of the trial are to evaluate (i) efficacy of reducing intrathecal pressure (ITP) by CSFD in patients with acute SCI; (ii) preliminary efficacy of combination of CSFD and elevation of MAP compared to elevation of MAP alone in improving neurologic motor outcomes in patients with acute SCI; and, (iii) safety of intensive CSFD in acute SCI patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSpinal Cord Injury
CountriesUnited States
CollaboratorsUniversity of Miami

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 13, 2015
Enrollment StartOct 1, 2015
Primary CompletionOct 25, 2019
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 11.0 years ago

Interventions

CSFD and elevation of MAPprocedure

Lumbar drain placement with CSFD with elevation of MAP

Maintenance of MAPprocedure

Lumbar drain placement without CSFD and with maintenance of MAP