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Steroid Treatment for
ASCI
Fiifi Brakatu
How Did We Get Here?
1972
n= 82
Control (no injury) = 8
Cats with 150 GCF ASCI
(untreated) = 33
Grp treated with IM steroids =
41
Cats treated with dexamethasone before or up to 24 h after cord injury have significandy better recovery and less
histological abnormality in the spinal cord than untreated cats, but the course of post-traumatic edema is similar.
1974
They demonstrated that K+ loss from cord happens in ASCI
Definite effect on Dexamethasone on D3 and statistically significant on D6 (p<0.01)
National Acute Spinal Cord Injury Studies
(NASCIS) I Trial - 1985
No significant difference was observed in neurological recovery of motor function, pinprick response, or touch sensation 1
year after injury between the two treatment groups
Lack of a steroid treatment effect.
Multicenter Double-blind
RCT
Compared 1g Dexa daily
x 10days with 100mg
Dexa x 10days
CFR - 10.7%
NASCIS II Trial - 1992
At 1yr - No significant difference in neurologic function
Those treated with methylprednisolone within 8hrs had a modest improvement in motor
recovery compared to placebo (p = 0.03)
Wound infections were more common in methylprednisolone group
Compared Methylprednisolone
(30mg/kg IV ff 5.4g/kg/hr over 23hrs)
with Naloxone and placebo in 427
TSCI patients
NASCIS III Trial - 1998
Patients treated within 3hrs had no diff in neurologic outcomes at 1yr
For patients treated btn 3-8h, 48hrs of MP was associated with greater motor but not functional recovery
Longer MP infusions = more cases of severe pneumonia and severe sepsis
Mortality was similar in all treatment groups
n=499
MP(x48h) vs MP(x24h) vs TM(a
potent lipid peroxidation inhibitor;
x 48h)
All 499 received bolus of
30mg/kg and Rx within 8hrs
Metanalysis - Only 3 RCTS! - 2012
NASCIS II trial + 2 other smaller
trials (one positive and one
negative)
Improved motor recovery (Not functional recovery!)
Surgical Timing in Acute Spinal Cord Injury
(STACIS) Trial - 2012 to 2019
Nonrandomized
prospective cohort study
6 North American
Centers; 7yr study
n=411
Patients who suffered a complication were less likely to have received glucocorticoid therapy (p=0.01), higher ASIA scores and more comorbidities
Limitations - Generalizability of model and suitability for clinical use remains unproven.
Societal Recommendations
STEROIDS NOT
RECOMMENDED
FOR ASCI!
STEROIDS ARE A
TREATMENT OPTION
NOT A TREATMENT
STANDARD
Meta-analysis - 2020
12 studies including
5RCTs and 7
observational studies
No statistically
significant increased
risk of GI bleeding,
Decubitus ulcers, SSIs,
Sepsis, Atelectasis,
VTEs, UTIs or mortality
MP within first 8h failed to show a statistically significant short term or long term improvement in
overall motor or neurological scores compared to controls who did not take MP. Increased risk of
pneumonia and hyperglycaemia among those who took MP.
NO CLINICAL EVIDENCE
EXISTS TO DEFINITELY
RECOMMEND THE USE OF
STEROID THERAPY
THANK YOU

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Steroid Treatment for ASCI: A History of Clinical Trials

  • 2. How Did We Get Here?
  • 3. 1972 n= 82 Control (no injury) = 8 Cats with 150 GCF ASCI (untreated) = 33 Grp treated with IM steroids = 41 Cats treated with dexamethasone before or up to 24 h after cord injury have significandy better recovery and less histological abnormality in the spinal cord than untreated cats, but the course of post-traumatic edema is similar.
  • 4. 1974 They demonstrated that K+ loss from cord happens in ASCI Definite effect on Dexamethasone on D3 and statistically significant on D6 (p<0.01)
  • 5. National Acute Spinal Cord Injury Studies (NASCIS) I Trial - 1985 No significant difference was observed in neurological recovery of motor function, pinprick response, or touch sensation 1 year after injury between the two treatment groups Lack of a steroid treatment effect. Multicenter Double-blind RCT Compared 1g Dexa daily x 10days with 100mg Dexa x 10days CFR - 10.7%
  • 6. NASCIS II Trial - 1992 At 1yr - No significant difference in neurologic function Those treated with methylprednisolone within 8hrs had a modest improvement in motor recovery compared to placebo (p = 0.03) Wound infections were more common in methylprednisolone group Compared Methylprednisolone (30mg/kg IV ff 5.4g/kg/hr over 23hrs) with Naloxone and placebo in 427 TSCI patients
  • 7. NASCIS III Trial - 1998 Patients treated within 3hrs had no diff in neurologic outcomes at 1yr For patients treated btn 3-8h, 48hrs of MP was associated with greater motor but not functional recovery Longer MP infusions = more cases of severe pneumonia and severe sepsis Mortality was similar in all treatment groups n=499 MP(x48h) vs MP(x24h) vs TM(a potent lipid peroxidation inhibitor; x 48h) All 499 received bolus of 30mg/kg and Rx within 8hrs
  • 8. Metanalysis - Only 3 RCTS! - 2012 NASCIS II trial + 2 other smaller trials (one positive and one negative) Improved motor recovery (Not functional recovery!)
  • 9. Surgical Timing in Acute Spinal Cord Injury (STACIS) Trial - 2012 to 2019 Nonrandomized prospective cohort study 6 North American Centers; 7yr study n=411 Patients who suffered a complication were less likely to have received glucocorticoid therapy (p=0.01), higher ASIA scores and more comorbidities Limitations - Generalizability of model and suitability for clinical use remains unproven.
  • 10. Societal Recommendations STEROIDS NOT RECOMMENDED FOR ASCI! STEROIDS ARE A TREATMENT OPTION NOT A TREATMENT STANDARD
  • 11. Meta-analysis - 2020 12 studies including 5RCTs and 7 observational studies No statistically significant increased risk of GI bleeding, Decubitus ulcers, SSIs, Sepsis, Atelectasis, VTEs, UTIs or mortality MP within first 8h failed to show a statistically significant short term or long term improvement in overall motor or neurological scores compared to controls who did not take MP. Increased risk of pneumonia and hyperglycaemia among those who took MP.
  • 12. NO CLINICAL EVIDENCE EXISTS TO DEFINITELY RECOMMEND THE USE OF STEROID THERAPY