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Table 4 Study drug safety and tolerability

From: Nebulized heparin is associated with fewer days of mechanical ventilation in critically ill patients: a randomized controlled trial

 

Placebo

N= 25

Heparin

N= 25

P value

Percentage of scheduled doses withheld

3.8 ± 9.2

5.8 ± 9.5

0.5

Reasons for withholding

   

   Blood-stained sputum

1 (4)

6 (24)

0.1

   Prolonged APTT

1 (4)

3 (12)

0.6

   Suspected HIT

0

1 (4)

1

   Confirmed HIT

1 (4)

0

1

   Invasive procedure

3 (12)

0

0.2

   Other

4 (16)

2 (8)

0.7

Percentage of days during study period with

   

   Blood-stained sputum

31 ± 28

41 ± 39

0.3

   Frank blood in sputum

2.5 ± 9

7.0 ± 21

0.3

   Purulent sputuma

62 ± 25

61 ± 35

1

Red cell transfusion

   

   Volume transfused per day (mls)

0 (0-57)

0 (0-85)

0.9

   Patients transfused

10 (40)

7 (28)

0.4

   Abnormal APTTb (> 40 seconds)

5/17 (29)

11/19 (58)

0.08

  1. aDenotes sputum reported as yellow, green, dirty, or purulent. bPatients on therapeutic heparin were excluded from this analysis. Values other than P values are presented as mean ± standard deviation, as median (interquartile range), or as number (percentage). APPT, activated partial thromboplastin time; HIT, heparin-induced thrombocytopenia.