Table 1 Demographics and injury characteristics of the included cohorts.

From: Pharmacological management of acute spinal cord injury: a longitudinal multi-cohort observational study

 

Sygen clinical trial (n = 797)

SCIRehab study (n = 1243)

Study details

 Study type

Prospective, double-blind, randomized, stratified, multicenter trial

Prospective observational study

 Study outcome

No differences between treatment and placebo groups in terms of neurological recovery

–

 Running time

1992–1998

2007–2010

 Country

United States of America

United States of America

Time of enrollment

< 72 h

Admission to rehabilitation center (30 ± 27 days post injury)

 Follow-up

1-year post-injury

Discharge from rehabilitation center

 References

PMID [11805612], [1180561], [2041549]

PMID [19810627]

Sex, n (%)

 Female

153 (19.2%)

231 (18.6%)

 Male

642 (80.6%)

1012 (81.4%)

 Missing

2 (0.3%)

–

Age or age groups (years)

 Mean (SD)

32.5 (13.4)

Not applicable

 Median [min, max]

30.0 [11.0, 69.0]

Not applicable

 Missing

2 (0.3%)

Not applicable

 12–19

150 (18.8%)

183 (14.7%)

 20–29

236 (29.6%)

340 (27.4%)

 30–39

194 (24.3%)

190 (15.3%)

 40–49

118 (14.8%)

201 (16.2%)

 50–59

55 (6.9%)

165 (13.3%)

 60–69

44 (5.5%)

106 (8.5%)

 70–79

–

45 (3.6%)

 80+

–

13 (1.0%)

AIS grade*, n (%)

 A

446 (56.0%)

624 (50.2%)

 B

77 (9.7%)

192 (15.4%)

 C

149 (18.7%)

230 (18.5%)

 D

31 (3.9%)

197 (15.8%)

 Missing

94 (11.8%)

–

Neurological level of injury, n (%)

 Cervical

599 (75.2%)

751 (60.4%)

 Thoracic

196 (24.6%)

46 (3.7%)

 Lumbar

–

446 (35.9%)

 Missing

2 (0.3%)

–

Paraplegia/tetraplegia, n (%)

 Paraplegia

189 (23.6%)

461 (37.1%)

 Tetraplegia

602 (76.1%)

782 (62.9%)

 Unknown

2 (0.3%)

–

Cause, n (%)

 Automobile

382 (47.9%)

441 (35.5%)

 Blunt trauma

9 (1.1%)

–

 Fall

129 (16.2%)

300 (24.1%)

 Gunshot wound

36 (4.5%)

125 (10.1%)

 Motorcycle

48 (6.0%)

110 (8.8%)

 Sports

35 (4.4%)

125 (10.1%)

 Others

61 (7.7%)

51 (4.1%)

 Pedestrian

10 (1.3%)

20 (1.6%)

 Person-to-person contact

–

10 (0.8%)

 Water related

85 (10.7%)

61 (4.9%)

 Missing

2 (0.3%)

–

  1. *American Spinal Injury Association Impairment Scale (AIS): AIS-A, no sensory or motor function is preserved in the sacral segments S4-5. AIS-B, sensory but no motor function is preserved below the neurological level and includes the sacral segments S4-5 (LT or PP at S4-5 or DAP), and no motor function is preserved more than three levels below the motor level on either side of the body. AIS-C, motor function is preserved at the most caudal sacral segments for voluntary anal contraction OR the patient meets the criteria for sensory incomplete status, and has some sparing of motor function more than three levels below the ipsilateral motor level on either side of the body. Less than half of key muscle functions below the single NLI have a muscle grade ≥ 3. AIS-D, motor incomplete status as defined above, with at least half (half or more) of key muscle functions below the single NLI having a muscle grade ≥ 3. AIS-E, if sensation and motor function as tested with the ISNCSCI are graded as normal in all segments, and the patient had prior deficits, then the AIS grade is E. Someone without an initial SCI does not receive an AIS grade.
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