Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT02495545 |
Recruitment Status :
Completed
First Posted : July 13, 2015
Last Update Posted : November 27, 2019
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Condition or disease | Intervention/treatment | Phase |
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Spinal Cord Injury | Procedure: CSFD and elevation of MAP Procedure: Maintenance of MAP | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Multi-Center, Randomized, Controlled, Trial of Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury |
Study Start Date : | October 2015 |
Actual Primary Completion Date : | October 25, 2019 |
Actual Study Completion Date : | October 25, 2019 |

Arm | Intervention/treatment |
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Experimental: CSFD with elevation of MAP
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.
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Procedure: CSFD and elevation of MAP
Lumbar drain placement with CSFD with elevation of MAP |
Active Comparator: Maintenance of MAP
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.
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Procedure: Maintenance of MAP
Lumbar drain placement without CSFD and with maintenance of MAP |
- Change in ITP [ Time Frame: 120 hours ]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).
- Change in International Standards for Classification of Spinal Cord Injury Motor Score (ISNCSCI, formerly ASIA) [ Time Frame: 180 days ]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.
- ISNCSCI Grade [ Time Frame: Change in ISNCSCI grade between 180 days and baseline ]
- ISNCSCI Sensory Scores [ Time Frame: Change in ISNCSCI Sensory Scores (Light Touch and Pin Prick) between 180 days and baseline ]
- ISNCSCI Upper Extremity Motor Score [ Time Frame: Change in ISNCSCI Upper Extremity Motor Score between 180 days and baseline ]
- ISNCSCI Lower Extremity Motor Score [ Time Frame: Change in ISNCSCI Lower Extremity Motor Score between 180 days and baseline ]
- Spinal Cord Independence Measure (SCIM) [ Time Frame: Spinal Cord Independence Measure (SCIM) at 180 days ]
- Pain level per patient report [ Time Frame: Pain Numeric Rating Scale (NRS) at 180 days ]Using a numeric pain rating scale, subjects will indicate level of pain at time measure occurs

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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 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).
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02495545
United States, Alabama | |
University of Alabama School of Medicine Department of Neurosurgery | |
Birmingham, Alabama, United States, 35294-3410 | |
United States, Arizona | |
Barrow Neurological Institute St. Joseph's Hospital and Medical Center | |
Phoenix, Arizona, United States, 85013 | |
University of Arizona Department of Surgery Division of Neurosurgery | |
Tucson, Arizona, United States, 85724-5070 |
Principal Investigator: | Nicholas Theodore, MD | Barrow Neurological Institute, St. Joseph's Hospital and Medical Center |
Responsible Party: | St. Joseph's Hospital and Medical Center, Phoenix |
ClinicalTrials.gov Identifier: | NCT02495545 |
Other Study ID Numbers: |
PHX 14BN084 |
First Posted: | July 13, 2015 Key Record Dates |
Last Update Posted: | November 27, 2019 |
Last Verified: | November 2019 |
spinal cord injury (SCI) |
Spinal Cord Injuries Cerebrospinal Fluid Leak Wounds and Injuries Spinal Cord Diseases Central Nervous System Diseases |
Nervous System Diseases Trauma, Nervous System Neurologic Manifestations Craniocerebral Trauma |