A Multi-Center, Randomized, Controlled, Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury

The purpose of this Phase IIB randomized control trial (RCT) is to evaluate the safety and efficacy of cerebrospinal fluid drainage (CSFD) and to provide a preliminary clinical efficacy evaluation of the combination of CSFD and elevation of MAP in patients with acute SCI. The objectives of this RCT are to evaluate (i) efficacy of reducing 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; (iii) safety of intensive CSFD in acute SCI patients.

Study phase: II

Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.

Aged 18—75 years inclusive; ?
Diagnosis of acute SCI; ?
Injury is less than 24 hours old; ?
ISNCSCI Impairment Scale Grade “A,” “B” or “C” based upon first ISNCSCI evaluation after arrival to the hospital; ?
Neurological level of injury between C4-C8 based upon first ISNCSCI evaluation after arrival to the hospital; ?
Women of childbearing potential must have a negative serum ?-hCG pregnancy test or a negative urine pregnancy test; ?
Patient is willing to participate in the study; ?
Informed consent document signed by patient or witnessed informed consent document; ?
No contraindications for study treatment(s); ?
Able to cooperate in the completion of a standardized neurological examination by ISNCSCI standards (includes patients who are on a ventilator).

Additional information:

Intervention:
Group 1-Lumbar drain placement with CSFD with maintenance of mean arterial pressure (MAP)
Group 2-Lumbar drain placement without CSFD and maintenance of MAP

Primary disease category: Orthopaedics, Muscle & Bone

Sponsor: Dignity Health and St. Joseph's Hsopital & Medical Center

Protocol number: CSFD-001 v 1.0

Projected enrollment dates: April 2015 to April 2017

Official study title: A Multi-Center, Randomized, Controlled, Trial of Cerebrospinal Fluid Drainage in Acute Spinal Cord Injury