Table 4 Safety data of patients receiving aprotinin and tranexamic acid

Myocardial infarction (ICU)

All patients

N

8

6

0.78

Open-heart procedures

0

2

0.04

All patients

% in group

1.4%

1.8%

Open-heart procedures

0.0%

1.9%

Myocardial infarction (late)

All patients

N

7

5

0.77

Open-heart procedures

1

1

0.60

All patients

% in group

1.3%

1.5%

Open-heart procedures

0.5%

1.0%

Seizures (ICU)

All patients

N

5

9

0.05

Open-heart procedures

4

7

0.04

All patients

% in group

0.9%

2.7%

Open-heart procedures

1.9%

6.7%

Seizures (late)

All patients

N

6

1

0.20

Open-heart procedures

3

1

0.74

All patients

% in group

1.1%

0.3%

Open-heart procedures

1.4%

1.0%

Ischemic stroke (ICU)

All patients

N

21

9

0.45

Open-heart procedures

10

6

0.68

All patients

% in group

3.8%

2.7%

Open-heart procedures

4.7%

5.7%

Ischemic stroke (late)

All patients

N

19

3

0.02

Open-heart procedures

9

1

0.12

All patients

% in group

3.4%

0.9%

Open-heart procedures

4.2%

1.0%

Neurologic disability (ICU)

All patients

N

21

11

0.85

Open-heart procedures

12

9

0.34

All patients

% in group

3.8%

3.3%

Open-heart procedures

5.6%

8.6%

Neurologic disability (late)

All patients

N

32

8

0.02

Open-heart procedures

15

1

0.03

All patients

% in group

5.8%

2.4%

Open-heart procedures

7.0%

1.0%

Intracerebral hemorrhage (ICU)

All patients

N

3

1

1.00

Open-heart procedures

2

1

1.00

All patients

% in group

0.5%

0.3%

Open-heart procedures

0.9%

1.0%

Intracerebral hemorrhage (late)

All patients

N

1

0

1.00

Open-heart procedures

0

0

n/a

All patients

% in group

0.2%

0.0%

Open-heart procedures

0.0%

0.0%

Mortality (in-hospital)

All patients

N

38

29

0.34

Open-heart procedures

16

17

0.02

All patients

% in group

6.9%

8.7%

Open-heart procedures

7.5%

16.2%