Spinal Cord InjuryNCT02495545
Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury
A study testing CSFD and elevation of MAP and Maintenance of MAP in people with Spinal Cord Injury, run by St. Joseph's Hospital and Medical Center, Phoenix at 3 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- CSFD and elevation of MAP and Maintenance of MAP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2015to 25 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Alabama School of Medicine Department of Neurosurgery
Birmingham, Alabama, 35294-3410
Barrow Neurological Institute St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of Arizona Department of Surgery Division of Neurosurgery
Tucson, Arizona, 85724-5070
About this study
Official title: A Multi-Center, Randomized, Controlled, Trial of Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury
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.
Read the detailed 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).
- Conditions
- Spinal Cord Injury
- Being tested
- CSFD and elevation of MAP, Maintenance of MAP
- Keywords
- spinal cord injury (SCI)
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CSFD and elevation of MAPProcedure or surgery
Lumbar drain placement with CSFD with elevation of MAP
Maintenance of MAPProcedure or surgery
Lumbar drain placement without CSFD and with maintenance of MAP
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Maintenance of MAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 180 days
Secondary outcomes (6)
ISNCSCI Grade
Measured: Change in ISNCSCI grade between 180 days and baseline
ISNCSCI Sensory Scores
Measured: Change in ISNCSCI Sensory Scores (Light Touch and Pin Prick) between 180 days and baseline
ISNCSCI Upper Extremity Motor Score
Measured: Change in ISNCSCI Upper Extremity Motor Score between 180 days and baseline
ISNCSCI Lower Extremity Motor Score
Measured: Change in ISNCSCI Lower Extremity Motor Score between 180 days and baseline
Spinal Cord Independence Measure (SCIM)
Measured: Spinal Cord Independence Measure (SCIM) at 180 days
Pain level per patient report
Using a numeric pain rating scale, subjects will indicate level of pain at time measure occurs
Measured: Pain Numeric Rating Scale (NRS) at 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2015 (estimated)
- Study startOct 2015
- Primary completion25 Oct 2019
- Study completion25 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Hospital and Medical Center, Phoenix
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Nicholas Theodore, MD, Principal investigator, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02495545
- Sponsor's protocol ID
- PHX 14BN084
- Status last verified
- Nov 2019
- First submitted
- 8 Jul 2015
- Last updated
- 27 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Amar AP, Levy ML. Pathogenesis and pharmacological strategies for mitigating secondary damage in acute spinal cord injury. Neurosurgery. 1999 May;44(5):1027-39; discussion 1039-40. doi: 10.1097/00006123-199905000-00052.
PubMed 10232536Bernhard M, Gries A, Kremer P, Bottiger BW. Spinal cord injury (SCI)--prehospital management. Resuscitation. 2005 Aug;66(2):127-39. doi: 10.1016/j.resuscitation.2005.03.005.
PubMed 15950358Brown PD, Davies SL, Speake T, Millar ID. Molecular mechanisms of cerebrospinal fluid production. Neuroscience. 2004;129(4):957-70. doi: 10.1016/j.neuroscience.2004.07.003.
PubMed 15561411Burke DA, Linden RD, Zhang YP, Maiste AC, Shields CB. Incidence rates and populations at risk for spinal cord injury: A regional study. Spinal Cord. 2001 May;39(5):274-8. doi: 10.1038/sj.sc.3101158.
PubMed 11438844Casha S, Christie S. A systematic review of intensive cardiopulmonary management after spinal cord injury. J Neurotrauma. 2011 Aug;28(8):1479-95. doi: 10.1089/neu.2009.1156. Epub 2010 Apr 8.
PubMed 20030558Coselli JS, LeMaire SA, Koksoy C, Schmittling ZC, Curling PE. Cerebrospinal fluid drainage reduces paraplegia after thoracoabdominal aortic aneurysm repair: results of a randomized clinical trial. J Vasc Surg. 2002 Apr;35(4):631-9. doi: 10.1067/mva.2002.122024.
PubMed 11932655DeVivo MJ, Chen Y. Trends in new injuries, prevalent cases, and aging with spinal cord injury. Arch Phys Med Rehabil. 2011 Mar;92(3):332-8. doi: 10.1016/j.apmr.2010.08.031.
PubMed 21353817Dohrmann GJ, Wick KM, Bucy PC. Spinal cord blood flow patterns in experimental traumatic paraplegia. J Neurosurg. 1973 Jan;38(1):52-8. doi: 10.3171/jns.1973.38.1.0052. No abstract available.
PubMed 4682352Fehlings MG, Tator CH, Linden RD. The relationships among the severity of spinal cord injury, motor and somatosensory evoked potentials and spinal cord blood flow. Electroencephalogr Clin Neurophysiol. 1989 Jul-Aug;74(4):241-59. doi: 10.1016/0168-5597(89)90055-5.
PubMed 2471626Francel PC, Long BA, Malik JM, Tribble C, Jane JA, Kron IL. Limiting ischemic spinal cord injury using a free radical scavenger 21-aminosteroid and/or cerebrospinal fluid drainage. J Neurosurg. 1993 Nov;79(5):742-51. doi: 10.3171/jns.1993.79.5.0742.
PubMed 8410254Guha A, Tator CH, Rochon J. Spinal cord blood flow and systemic blood pressure after experimental spinal cord injury in rats. Stroke. 1989 Mar;20(3):372-7. doi: 10.1161/01.str.20.3.372.
PubMed 2922776Hadley MN, Walters BC. Introduction to the Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries. Neurosurgery. 2013 Mar;72 Suppl 2:5-16. doi: 10.1227/NEU.0b013e3182773549. No abstract available.
PubMed 23417174Hadley MN, Walters BC, Grabb PA, Oyesiku NM, Przybylski GJ, Resnick DK, Ryken TC, Mielke DH. Guidelines for the management of acute cervical spine and spinal cord injuries. Clin Neurosurg. 2002;49:407-98. No abstract available.
PubMed 12506565Hickey R, Albin MS, Bunegin L, Gelineau J. Autoregulation of spinal cord blood flow: is the cord a microcosm of the brain? Stroke. 1986 Nov-Dec;17(6):1183-9. doi: 10.1161/01.str.17.6.1183.
PubMed 3810718Horn EM, Theodore N, Assina R, Spetzler RF, Sonntag VK, Preul MC. The effects of intrathecal hypotension on tissue perfusion and pathophysiological outcome after acute spinal cord injury. Neurosurg Focus. 2008;25(5):E12. doi: 10.3171/FOC.2008.25.11.E12.
PubMed 18980472
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Controlled, Trial of Cerebrospinal Fluid Drainage (CSFD) in Acute Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02495545
- Acronym / sponsor ID
- PHX 14BN084
- Conditions
- Spinal Cord Injury
- Keywords
- spinal cord injury (SCI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- St. Joseph's Hospital and Medical Center, PhoenixUniversity, hospital or other
- Collaborators
- University of Miami
- Study start
- Oct 2015
- Primary completion
- 25 Oct 2019 (actual)
- Study completion
- 25 Oct 2019 (actual)
- First posted
- 13 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CSFD with elevation of MAP | Experimental | Procedure: CSFD and elevation of MAPSubjects 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. |
| Maintenance of MAP | Active comparator | Procedure: Maintenance of MAPSubjects 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CSFD and elevation of MAPLumbar drain placement with CSFD with elevation of MAP | Procedure or surgery | CSFD with elevation of MAP |
| Maintenance of MAPLumbar drain placement without CSFD and with maintenance of MAP | Procedure or surgery | Maintenance of MAP |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Background: PubMed 10232536Amar AP, Levy ML. Pathogenesis and pharmacological strategies for mitigating secondary damage in acute spinal cord injury. Neurosurgery. 1999 May;44(5):1027-39; discussion 1039-40. doi: 10.1097/00006123-199905000-00052.
- Background: PubMed 15950358Bernhard M, Gries A, Kremer P, Bottiger BW. Spinal cord injury (SCI)--prehospital management. Resuscitation. 2005 Aug;66(2):127-39. doi: 10.1016/j.resuscitation.2005.03.005.
- Background: PubMed 15561411Brown PD, Davies SL, Speake T, Millar ID. Molecular mechanisms of cerebrospinal fluid production. Neuroscience. 2004;129(4):957-70. doi: 10.1016/j.neuroscience.2004.07.003.
- Background: PubMed 11438844Burke DA, Linden RD, Zhang YP, Maiste AC, Shields CB. Incidence rates and populations at risk for spinal cord injury: A regional study. Spinal Cord. 2001 May;39(5):274-8. doi: 10.1038/sj.sc.3101158.
- Background: PubMed 20030558Casha S, Christie S. A systematic review of intensive cardiopulmonary management after spinal cord injury. J Neurotrauma. 2011 Aug;28(8):1479-95. doi: 10.1089/neu.2009.1156. Epub 2010 Apr 8.
- Background: PubMed 11932655Coselli JS, LeMaire SA, Koksoy C, Schmittling ZC, Curling PE. Cerebrospinal fluid drainage reduces paraplegia after thoracoabdominal aortic aneurysm repair: results of a randomized clinical trial. J Vasc Surg. 2002 Apr;35(4):631-9. doi: 10.1067/mva.2002.122024.
- Background: PubMed 21353817DeVivo MJ, Chen Y. Trends in new injuries, prevalent cases, and aging with spinal cord injury. Arch Phys Med Rehabil. 2011 Mar;92(3):332-8. doi: 10.1016/j.apmr.2010.08.031.
- Background: PubMed 4682352Dohrmann GJ, Wick KM, Bucy PC. Spinal cord blood flow patterns in experimental traumatic paraplegia. J Neurosurg. 1973 Jan;38(1):52-8. doi: 10.3171/jns.1973.38.1.0052. No abstract available.
- Background: PubMed 2471626Fehlings MG, Tator CH, Linden RD. The relationships among the severity of spinal cord injury, motor and somatosensory evoked potentials and spinal cord blood flow. Electroencephalogr Clin Neurophysiol. 1989 Jul-Aug;74(4):241-59. doi: 10.1016/0168-5597(89)90055-5.
- Background: PubMed 8410254Francel PC, Long BA, Malik JM, Tribble C, Jane JA, Kron IL. Limiting ischemic spinal cord injury using a free radical scavenger 21-aminosteroid and/or cerebrospinal fluid drainage. J Neurosurg. 1993 Nov;79(5):742-51. doi: 10.3171/jns.1993.79.5.0742.
- Background: PubMed 2922776Guha A, Tator CH, Rochon J. Spinal cord blood flow and systemic blood pressure after experimental spinal cord injury in rats. Stroke. 1989 Mar;20(3):372-7. doi: 10.1161/01.str.20.3.372.
- Background: PubMed 23417174Hadley MN, Walters BC. Introduction to the Guidelines for the Management of Acute Cervical Spine and Spinal Cord Injuries. Neurosurgery. 2013 Mar;72 Suppl 2:5-16. doi: 10.1227/NEU.0b013e3182773549. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicholas Theodore, MD principal investigator
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CSFD and elevation of MAP and Maintenance of MAP in people with Spinal Cord Injury, run by St. Joseph's Hospital and Medical Center, Phoenix at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ITP (time frame: 120 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02495545, which also lists 36 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.