Early fibrinogen concentrate therapy for major haemorrhage in trauma (E-FIT 1): results from a UK multi-centre, randomised, double blind, placebo-controlled pilot trial

Table 4 Serious adverse events

	Fibrinogen concentrate arm	Placebo arm
Subjects
Number of participants in receipt of the study intervention	20	19
Number of participants experiencing at least one SAE^a	13	11
Number of SAEs	29	21
Symptomatic thrombotic events	3	2
Arterial
MI	0	0
Stroke	1	1
Other (arterial thrombus)	0	1
Venous
DVT	0	0
PE	2	0
Sepsis	4	6
Organ failure	10	2
Multiple organ failure	4	1
Single organ failure	6	1
New-onset major bleeding	1	3
Uncontrolled major bleeding^b	2	1
Other SAEs	9	7
Death
All deaths^c	8	3
Death due to bleeding	2 (25%)	1 (33%)

Abbreviations: DVT Deep venous thrombosis, MI Myocardial infarction, PE Pulmonary embolus, SAE Serious adverse event
Safety data were collected for only the 39 participants who were administered the study intervention
^aEleven participants experienced more than one SAE
^bMajor bleeding that was not controlled at any time from admission
^cIncludes all cases of multi-organ failure, all cases of uncontrolled bleeding, one case of single organ failure in the active treatment arm and two other SAEs (one in the active treatment arm and one in the placebo arm)

ISSN: 1364-8535