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F7Trauma1648

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Title: F7Trauma1648

1
F7Trauma-1648

2
Objective

3
Inclusion criteria

Informed consent obtained before any trial
related activities
Blunt and or penetrating trauma injury with
evidence of active torso hemorrhage refractory to
blood component therapy and surgical hemostatic
procedures (proximal to the inguinal creases,
proximal/medial to the axilla.

4
Inclusion criteria, continued

Evidence of active torso hemorrhage as defined
as
Presence of acidosis (lactate gt6mmol/L(2
times the local upper limit of normal-4.4) or
Base Deficit 5mEq/L)
OR
Presence of hypotension (SBP 90 mmHg)
OR

5
Inclusion criteria continued

Presence of ongoing volume loading at a
minimal rate of 1L/h (RBC or any other IV
fluid/blood product and with continuing similar
or greater need per the investigators judgment)
Receipt of a minimum of 4 units of RBC and the
ability to administer study drug as soon as
possible

6
Inclusion criteria continued

Upon completion of the 4th unit and before
the completion of the 8th unit of blood.
Male or female patients, between 18-65 years of
age or of legal age to consent per local law.

7
Exclusion criteria

Known age of lt18 or gt65 years of age or not of
legal age to consent to participation in an
investigational drug trial according to local
law.
Moribund as defined by
pH 7.1 OR
SBP 50 mmHg or use of repeated bolus vasopressor
treatment to support the blood pressure prior to
randomization (bolus vasopressor use for reasons
other than hypovolemia (i.e. spinal cord injury,
anesthetic induction) does not exclude patient. OR

8
Exclusion criteria continued

Moribund as defined by (cont.)
Base Deficit (BD) gt 15 mEqL/ OR
Lactate gt 15 mmol/L OR
Anatomical injury incompatible with life (e.g.
multiple cardiac wounds, unrepairable liver or
pelvic injury) OR
Glascow Coma Scale (GCS) score never gt 5 at any
time between injury and randomization in patients
with any type of injury OR
Cardiac arrest any time from injury prior to
randomization

9
Exclusion criteria continued

Evidence of head injury and suspicion of SEVERE
brain trauma defined as any of the following
GCS8 and cranial CT showing AIS gt 3 OR
Abnormal physical exam (e.g. decorticate
posturing) indicating brain injury OR
Intracranial injury AIS gt 3 on CT

10
Exclusion criteria continued

Time of injury to randomization gt 12 hours
Estimated time from injury to trial hospital
admission gt 4 hours
Primary bleeding source localized to the
extremities as per the investigators judgment
Treatment with aprotinin and aPCC or intention to
treat with aprotinin and aPCC from injury thru
day 5

11
Exclusion criteria continued

Known history of thromboembolic events within 30
days
Presence of spinal cord injury above T6 with
paralysis
Total body surface area burns 2 3 40
(evaluated by the investigator using Lund-Browder
chart for est. extent of burns)
Known or suspected pregnancy

12
Exclusion criteria continued