Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury

Spinal Cord Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02495545
• Other study ID #: PHX 14BN084
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: October 25, 2019

Study information

• Verified date: November 2019
• Source: St. Joseph's Hospital and Medical Center, Phoenix
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Acute spinal cord injury (SCI) affects 10,000-14,000 persons per year in the United States (Burke, Linden et al. 2001). There are 150,000-300,000 persons living with significant disabilities from SCI at any given time (Bernhard, Gries et al. 2005). The average age of incident cases of SCI is 47 years and about 78% of the cases are males (DeVivo and Chen 2011). Estimates of the lifetime costs to care for someone with a SCI range from $325,000 to $1.35 million and the yearly cost to society reaches $8 billion (Sekhon and Fehlings 2001). With better long term care technologies, these costs are expected to continue to rise. Although there have been significant advances in accessibility for people with disabilities, the goal of medical science is to overcome the physiological barriers imposed by the injury itself and allow these individuals to regain their pre-injury level of neurological function (Rowland, Hawryluk et al. 2008). The injury to the spinal cord occurs in two phases. The first phase is the primary physical damage due to the impact energy of the compressive nature of the injury. The damage can be very complex with shearing of the axons, destruction of the cell bodies and disruption of the microvasculature at the site of injury. The secondary phase of the injury begins soon after the primary injury has occurred and can be influenced by many factors such as hypoxia, hypotension, and the extent of the primary injury. Spinal cord ischemia post-injury causes a significant increase in cell death and more significant neurological disability. Limiting tissue hypoperfusion post-injury can decrease the amount of cell death and axonal damage. Lumbar cerebrospinal fluid drainage (CSFD) together with increased mean arterial blood pressure (MAP) in the immediate post-injury period can reduce spinal cord tissue hypoperfusion. By reducing spinal cord hypoperfusion through elevation of MAP, less cell death and axonal damage will occur, leading to an improvement in neurological function. The feasibility of CSFD as a means for reducing the intrathecal pressure (ITP) in patients with acute SCI has been demonstrated in a small randomized controlled trial by Kwon et al (Kwon, Curt et al. 2009). The limitations were a small sample size, broad inclusion criteria, lack of statistical power calculation and restricted drainage regimen (maximum 10 mL per hour).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 ß-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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Cerebrospinal Fluid Leak
• Spinal Cord Injuries
• Spinal Cord Injury
• Wounds and Injuries

Intervention

Procedure:
• CSFD and elevation of MAP
Lumbar drain placement with CSFD with elevation of MAP
• Maintenance of MAP
Lumbar drain placement without CSFD and with maintenance of MAP

Locations

Country	Name	City	State
United States	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

Sponsors (2)

Lead Sponsor	Collaborator
St. Joseph's Hospital and Medical Center, Phoenix	University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	ISNCSCI Grade		Change in ISNCSCI grade between 180 days and baseline
Secondary	ISNCSCI Sensory Scores		Change in ISNCSCI Sensory Scores (Light Touch and Pin Prick) between 180 days and baseline
Secondary	ISNCSCI Upper Extremity Motor Score		Change in ISNCSCI Upper Extremity Motor Score between 180 days and baseline
Secondary	ISNCSCI Lower Extremity Motor Score		Change in ISNCSCI Lower Extremity Motor Score between 180 days and baseline
Secondary	Spinal Cord Independence Measure (SCIM)		Spinal Cord Independence Measure (SCIM) at 180 days
Secondary	Pain level per patient report	Using a numeric pain rating scale, subjects will indicate level of pain at time measure occurs	Pain Numeric Rating Scale (NRS) at 180 days