Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury

Completed · Not applicable

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT02495545

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

15

Starts

2015-10-01

Expected to finish

2019-10-25

Last updated by the study team

2019-11-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 β-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).

You may not qualify if…

• Injury arising from penetrating mechanism;
• Significant concomitant head injury defined by a Glasgow Coma Scale (GCS) score < 14 with a clinically significant abnormality on a head CT (head CT required only for patients suspected to have a brain injury at the discretion of the investigator);
• Pre-existing neurologic or mental disorder which would preclude accurate evaluation and follow-up (i.e. Alzheimer's disease, Parkinson's disease, unstable psychiatric disorder with- hallucinations and/or delusions or schizophrenia);
• Prior history of SCI;
• Recent history (less than 1 year) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation, in the opinion of the investigator;
• Is a prisoner;
• Participation in another clinical trial within the past 30 days;
• Acquired immune deficiency syndrome (AIDS) or AIDS-related complex;
• Active malignancy or history of invasive malignancy within the last five years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitely treated. Patients with carcinoma in situ of the uterine cervix treated definitely more than 1 year prior to enrollment may enter the study.

Where it is running

• University of Alabama School of Medicine Department of Neurosurgery — Birmingham, Alabama, United States
• Barrow Neurological Institute St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• University of Arizona Department of Surgery Division of Neurosurgery — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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