Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury

NCT02495545 | Completed DMC

• 1 other identifier: PHX 14BN084
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

spinal cord injury (SCI)

Outcome Measures

Primary Outcomes (2)

• Change in ITP

  ITP will be measured in both groups every hour for the duration of study treatment for a total of 121 measurements consisting of one pre-treatment measurement (time 0 hours) and 120 measurements during the treatment (time 1-120 hours).

  120 hours

• Change in International Standards for Classification of Spinal Cord Injury Motor Score (ISNCSCI, formerly ASIA)

  ISNCSCI Motor Score will be obtained at hospital arrival (baseline), 72 hours post-injury, 84 days and 180 days post-treatment. The primary endpoint is difference between the Motor Score at 180 days and baseline.

  180 days

Secondary Outcomes (6)

• ISNCSCI Grade

  Change in ISNCSCI grade between 180 days and baseline

• ISNCSCI Sensory Scores

  Change in ISNCSCI Sensory Scores (Light Touch and Pin Prick) between 180 days and baseline

• ISNCSCI Upper Extremity Motor Score

  Change in ISNCSCI Upper Extremity Motor Score between 180 days and baseline

• ISNCSCI Lower Extremity Motor Score

  Change in ISNCSCI Lower Extremity Motor Score between 180 days and baseline

• Spinal Cord Independence Measure (SCIM)

  Spinal Cord Independence Measure (SCIM) at 180 days

Study Arms (2)

CSFD with elevation of MAP

EXPERIMENTAL

Subjects will receive CSFD and elevation of MAP. Treatments will be 120 hours (5 days) from time treatment is initiated (time 0), and within 24 hours of time of injury. Initiation of CSFD will occur after decompression (during surgery) with a target ITP of 10 mmHg. MAP elevation (norepinephrine drip; goal 100-110 mmHg) will start during surgery, simultaneously with CSFD. 10 mL of CSF will be collected daily for routine lab testing. Post-surgery subjects will be transferred to an intensive care unit (ICU) for duration of treatment or longer if clinically indicated. Target MAP will be sustained within 100-110 mmHg for 5 days. Norepinephrine drip will be used to maintain MAP goal. Subjects will receive other treatment per standard of care at the participating investigational sites.

Procedure: CSFD and elevation of MAP

Maintenance of MAP

ACTIVE COMPARATOR

Subjects will receive elevation of MAP (norepinephrine drip; goal 85-90 mm Hg). Target MAP will be sustained within 85-90 mmHg in the control group for 5 days. Duration of elevation of MAP treatment will be 120 hours (5 days) from time treatment is (time 0). Subjects will receive the same treatment as the subjects in investigational arm except for the initiation of the CSFD and less aggressive MAP elevation. They will have a drain placed the same way as the experimental subjects. While drain is in place, 10 mL of cerebrospinal fluid will be collected daily for laboratory testing. After that, ITP will be monitored but CSFD will not be initiated. Subjects will receive other treatment per standard of care at participating investigational sites.

Procedure: Maintenance of MAP

Interventions

CSFD and elevation of MAP PROCEDURE

Lumbar drain placement with CSFD with elevation of MAP

CSFD with elevation of MAP

Maintenance of MAP PROCEDURE

Lumbar drain placement without CSFD and with maintenance of MAP

Maintenance of MAP

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• University of Miami: collaborator

Study Sites (3)

University of Alabama School of Medicine Department of Neurosurgery

Birmingham, Alabama, 35294-3410, United States

Location

Barrow Neurological Institute St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

Location

University of Arizona Department of Surgery Division of Neurosurgery

Tucson, Arizona, 85724-5070, United States

Location

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MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Nicholas Theodore, MD

  Barrow Neurological Institute, St. Joseph's Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2015
• First Posted: July 13, 2015
• Study Start: October 1, 2015
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: November 27, 2019

Record last verified: 2019-11

Locations

US (3)