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Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury

NCT02495545 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2019-11-27

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury

Interventions

PROCEDURE

CSFD and elevation of MAP

Lumbar drain placement with CSFD with elevation of MAP

PROCEDURE

Maintenance of MAP

Lumbar drain placement without CSFD and with maintenance of MAP

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • St. Joseph's Hospital and Medical Center, Phoenix

    lead OTHER

Principal Investigators

  • Nicholas Theodore, MD · Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2019-10-25
Completion
2019-10-25

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02495545 on ClinicalTrials.gov