Minocycline and Perfusion Pressure Augmentation in Acute Spinal Cord Injury
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ClinicalTrials.gov Identifier: NCT00559494 |
Recruitment Status
:
Completed
First Posted
: November 16, 2007
Last Update Posted
: March 18, 2013
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injuries | Drug: Minocycline Drug: placebo Procedure: SCPP augmentation Procedure: SCPP control | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 52 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Study to Assess Clinical Safety and Tolerance of Minocycline and Spinal Perfusion Pressure Augmentation in Acute Spinal Cord Injury |
Study Start Date : | June 2004 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | August 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Minocycline |
Drug: Minocycline
Minocycline IV BID x 7 days (first 10 patients 200 mg/dose, subsequent patients adjusted based on pharmacodynamic profiling to 800 mg loading dose, tapered 100 mg each dose to 400 mg then maintain at 400mg until day 7)
Other Name: Minocin
|
Placebo Comparator: Placebo |
Drug: placebo
Normal saline 250cc via central line similar to minocycline arm administration protocol
Other Names:
|
Experimental: SCPP augmentation |
Procedure: SCPP augmentation
maintenance of spinal cord perfusion pressure at 75 mmHg with fluids and inotrope protocol
|
Sham Comparator: SCPP control |
Procedure: SCPP control
maintenance of Mean arterial pressure of >65 mmHg with fluids and inotropes protocol without spinal cord perfusion pressure as target or guiding therapy
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- Protocol compliance, feasibility and adverse events [ Time Frame: 2 years ]
- American Spinal Injury Association - motor score (primary clinical outcome) and sensory scores [ Time Frame: 2 years ]
- Short Form 36 - Quality of Life Assessment [ Time Frame: 2 years ]
- Functional Independence Measure [ Time Frame: 2 years ]
- London Handicap Scale [ Time Frame: 2 years ]
- Spinal Cord Injury Measure [ Time Frame: 2 years ]
- CSF collection (6/day) and biochemical assays [ Time Frame: 7 days ]
- Sequential Anatomical MRI [ Time Frame: 1 year ]

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 16 or over
- Motor complete or motor incomplete acute spinal cord injury involving bony spinal levels between C0 and T11
- Patient able to provide informed consent
- Randomization and commencement of administration of first drug dose within 12 hours of injury
- surgical decompression if needed to be performed within 24 hours of the injury
- subjects exhibiting spinal cord perfusion pressure (lumbar drain transduced pressure - mean arterial pressure)> 75 mmHg will be randomized to active augmentation protocol versus maintenance of mean arterial pressure
Exclusion Criteria:
- Acute spinal cord injury >12 hours old
- Isolated sensory deficit, motor intact
- Isolated cauda equina injury or injury at bony level T12 or below
- History of systemic lupus erythematosus (SLE)
- Pre-existing hepatic or renal disease
- Tetracycline hypersensitivity
- Pregnancy or breast feeding
- Isolated sensory deficit
- Isolated radicular motor deficit
- Significant leukopenia (white blood cell count < ½ times the lower limit of normal) at screening
- Elevated liver function tests (AST, ALT, alkaline phosphatase, or total bilirubin > 2 times the upper limit of normal) at screening
- Presence of systemic disease that might interfere with patient safety, compliance or evaluation of the condition under study (e.g. insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1)
- Associated traumatic conditions interfering with informed consent or outcome assessment (e.g. closed head injury, liver contusion)
- Known uncorrected severe coronary artery disease or evidence of active coronary ischemia (ECG changes, positive Troponin) will be excluded from SCPP randomization

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): NCT00559494
Canada, Alberta | |
Foothills Medical Centre | |
Calgary, Alberta, Canada, T2N 2T9 |
Principal Investigator: | Steven Casha, MD PhD FRCSC | University of Calgary | |
Principal Investigator: | R. John Hurlbert, MD PhD FRCSC | University of Calgary | |
Principal Investigator: | David Zygun, MD MSc | University of Calgary |
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Steve Casha, Assistant Professor, University of Calgary |
ClinicalTrials.gov Identifier: | NCT00559494 History of Changes |
Other Study ID Numbers: |
17007 PVA2414 ( Other Grant/Funding Number: Paralyzed Veterans of America ) |
First Posted: | November 16, 2007 Key Record Dates |
Last Update Posted: | March 18, 2013 |
Last Verified: | March 2013 |
Keywords provided by Steve Casha, University of Calgary:
complete spinal cord injury incomplete spinal cord injury central cord spinal cord injury traumatic |
Additional relevant MeSH terms:
Wounds and Injuries Spinal Cord Injuries Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases |
Trauma, Nervous System Minocycline Anti-Bacterial Agents Anti-Infective Agents |