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Table 4 Serious adverse events

From: 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

  Fibrinogen concentrate arm Placebo arm
Subjects
Number of participants in receipt of the study intervention 20 19
Number of participants experiencing at least one SAEa 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 bleedingb 2 1
Other SAEs 9 7
Death
 All deathsc 8 3
  Death due to bleeding 2 (25%) 1 (33%)
  1. Abbreviations: DVT Deep venous thrombosis, MI Myocardial infarction, PE Pulmonary embolus, SAE Serious adverse event
  2. Safety data were collected for only the 39 participants who were administered the study intervention
  3. aEleven participants experienced more than one SAE
  4. bMajor bleeding that was not controlled at any time from admission
  5. 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)