Table 6.

Unadjusted change in PT and PTT 1 hour after first transfusion




Mean before transfusion ± SD, s (min, max)

Mean after transfusion ± SD, s (min, max)

Mean unadjusted change ± SD, s (min, max)

P*

Treatment difference of means

95% CI
Efficacy-evaluable population       
   PT        
      Test; n = 58   22.3 ± 10.6 (10.5, 83.9)   18.8 ± 4.5 (12.2, 32.6)   3.5 ± 9.3 (–5.2, 65.3)   .002   –0.2   –3.0, 2.5  
      Control; n = 58   21.9 ± 6.5 (11.4, 40.8)   18.2 ± 3.5 (11.4, 26.0)   3.7 ± 5.4 (–6.1, 18.6)   —   —   —  
   PTT        
      Test; n = 56   42.5 ± 13.4 (25.3, 99.2)   39.3 ± 11.2 (26.3, 96.8)   3.1 ± 11.0 (–34.6, 45.3)   .348   1.3   –6.0, 8.6  
      Control; n = 55   43.6 ± 16.8 (27.5, 133.1)   41.4 ± 23.0 (23.6, 200.0)   1.8 ± 25.5 (–157.4, 66.3)   —   —   —  
OLT population       
   PT        
      Test; n = 22   19.4 ± 7.2 (10.5, 40.9)   17.7 ± 5.5 (12.2, 32.6)   1.7 ± 5.7 (–5.2, 19.6)   .103   –1.7   –5.2, 1.8  
      Control; n = 26   19.9 ± 7.2 (11.4, 40.8)   16.5 ± 3.3 (11.4, 23.3)   3.4 ± 6.6 (–6.1, 18.6)   —   —   —  
   PTT        
      Test; n = 22   39.1 ± 12.4 (25.6, 76.4)   37.9 ± 14.2 (27.4, 96.8)   1.2 ± 15.1 (–34.6, 45.3)   .890   –4.1   –13.5, 5.2  
      Control; n = 25   42.7 ± 21.2 (28.2, 133.1)   36.9 ± 8.7 (23.6, 66.8)   5.3 ± 17.5 (–17.6, 66.3)   —   —   —  
Non-OLT population       
   PT        
      Test; n = 36   24.0 ± 12.0 (15.9, 83.9)   19.5 ± 3.7 (15.1, 28.3)   4.5 ± 10.9 (–0.9, 65.3)   .042   0.6   –3.2, 4.5  
      Control; n = 32   23.6 ± 5.5 (14.9, 34.1)   19.6 ± 3.0 (12.4, 26.0)   3.9 ± 4.2 (–3.0, 17.3)   —   —   —  
   PTT        
      Test; n = 34   44.6 ± 13.7 (25.3, 99.2)   40.2 ± 8.9 (26.3, 72.7)   4.3 ± 7.4 (–5.1, 26.5)   .907   5.5   –5.7, 16.7  
      Control; n = 30
 
44.4 ± 12.6 (27.5, 94.7)
 
45.3 ± 29.8 (27.0, 200)
 
–1.2 ± 30.6 (–157.4, 36.7)
 

 

 

 



Mean before transfusion ± SD, s (min, max)

Mean after transfusion ± SD, s (min, max)

Mean unadjusted change ± SD, s (min, max)

P*

Treatment difference of means

95% CI
Efficacy-evaluable population       
   PT        
      Test; n = 58   22.3 ± 10.6 (10.5, 83.9)   18.8 ± 4.5 (12.2, 32.6)   3.5 ± 9.3 (–5.2, 65.3)   .002   –0.2   –3.0, 2.5  
      Control; n = 58   21.9 ± 6.5 (11.4, 40.8)   18.2 ± 3.5 (11.4, 26.0)   3.7 ± 5.4 (–6.1, 18.6)   —   —   —  
   PTT        
      Test; n = 56   42.5 ± 13.4 (25.3, 99.2)   39.3 ± 11.2 (26.3, 96.8)   3.1 ± 11.0 (–34.6, 45.3)   .348   1.3   –6.0, 8.6  
      Control; n = 55   43.6 ± 16.8 (27.5, 133.1)   41.4 ± 23.0 (23.6, 200.0)   1.8 ± 25.5 (–157.4, 66.3)   —   —   —  
OLT population       
   PT        
      Test; n = 22   19.4 ± 7.2 (10.5, 40.9)   17.7 ± 5.5 (12.2, 32.6)   1.7 ± 5.7 (–5.2, 19.6)   .103   –1.7   –5.2, 1.8  
      Control; n = 26   19.9 ± 7.2 (11.4, 40.8)   16.5 ± 3.3 (11.4, 23.3)   3.4 ± 6.6 (–6.1, 18.6)   —   —   —  
   PTT        
      Test; n = 22   39.1 ± 12.4 (25.6, 76.4)   37.9 ± 14.2 (27.4, 96.8)   1.2 ± 15.1 (–34.6, 45.3)   .890   –4.1   –13.5, 5.2  
      Control; n = 25   42.7 ± 21.2 (28.2, 133.1)   36.9 ± 8.7 (23.6, 66.8)   5.3 ± 17.5 (–17.6, 66.3)   —   —   —  
Non-OLT population       
   PT        
      Test; n = 36   24.0 ± 12.0 (15.9, 83.9)   19.5 ± 3.7 (15.1, 28.3)   4.5 ± 10.9 (–0.9, 65.3)   .042   0.6   –3.2, 4.5  
      Control; n = 32   23.6 ± 5.5 (14.9, 34.1)   19.6 ± 3.0 (12.4, 26.0)   3.9 ± 4.2 (–3.0, 17.3)   —   —   —  
   PTT        
      Test; n = 34   44.6 ± 13.7 (25.3, 99.2)   40.2 ± 8.9 (26.3, 72.7)   4.3 ± 7.4 (–5.1, 26.5)   .907   5.5   –5.7, 16.7  
      Control; n = 30
 
44.4 ± 12.6 (27.5, 94.7)
 
45.3 ± 29.8 (27.0, 200)
 
–1.2 ± 30.6 (–157.4, 36.7)
 

 

 

 

P < .05 indicates rejection of inferiority.

*

Testing for equivalence between the test and control with an equivalence margin of 4.6 and 4.8 seconds for PT and PTT, respectively

Two-sided 95% CI for treatment difference; test minus control using z statistic

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