Use of Rotational Thromboelastometry (ROTEM) to Characterize Coagulation Abnormalities in Burn Patients

Specific aims of this pilot study are to use bedside blood analysis with ROTEM in severe burn
patients to provide preliminary information on the nature of coagulation abnormalities and to
compare subject ROTEM coagulation profiles within 24 hours of burn injury (day 1) and on days
2, 3, 5, 7, 14 and 21 after burn injury. Investigators hypothesize that ROTEM analysis will
detect a pattern of impaired coagulation in severely burned patients.

ROTEM analysis:

A blood sample and reagents are placed into a small cup. A pin suspended from a wire is
immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of
the pin is optically monitored and converted into a real time measurement that is represented
graphically. Prior to clot formation, pin rotation is unhindered and is graphically
represented as a straight line. As the subject's blood sample starts to clot, strands of clot
form between the pin and the cup wall, restricting the movement of the pin depending on the
strength of the clot. Graphically, this is represented as a symmetrical widening of the
curve. Blood will be obtained for ROTEM/ fibrinogen levels from each subject seven times
during their hospital admission: once within 24 hours of burn injury (day 1), and on days 2,
3, 5, 7, 14 and 21. For each sample, 5.4 mL of whole blood will be collected into 2 citrated
tubes (2.7 mL in each tube). For all subjects, both pediatric and adult, blood will be
collected via an indwelling catheter (arterial or central line). One 2.7 ml tube will be used
for ROTEM analysis. The amount of blood is in accordance with the acceptable limit of ROTEM
analysis. ROTEM testing will be performed according to the manufacturer's instructions using
test kit reagents. Members of the clinical research team who have been trained and certified
to use the ROTEM device will perform the appropriate ROTEM tests. The second 2.7 mL citrated
tube will be used to measure fibrinogen level, using the automated central laboratory device
in hospital.

In this interventional study, the ROTEM data will be blinded to the treating Burn ICU
physicians and will have no effect on standard perioperative and ICU treatment. The ROTEM
machine will be located in a designated spot outside of the ICU, out of view of the treating
clinicians. Thus, volume replacement, thrombosis prophylaxis, and other management (including
blood product transfusions) will be performed according to existing protocols.

Demographic information will be de-identified, but will include demographics (age, sex) and
each subject's medical and surgical history, burn injury type (thermal, chemical, electrical,
inhalational, plus/minus additional injury - i.e. Trauma/TBI, etc) and percent Total Body
Surface Area (TBSA) as diagrammed by the Burn ICU on admission, medications (specifically,
form of venous thromboembolism prophylaxis as prescribed by ICU physicians during the study
period), weight, vital signs, dates of surgical intervention (bedside escharotomies and OR
procedures), dates and types of blood product administration, fluid balance per day, number
of days intubated, number of ICU days, hospital LOS, mortality, and ISS. Laboratory values:
(on days 1, 2, 3, 5, 7, 14, and 21) will include fibrinogen, PT, INR, aPTT, and CBC when
available as standard of care.

Inclusion Criteria:

1. Consecutive patients admitted to NYPH with 15% TBSA burn or greater.

2. Patients with vascular access catheters (arterial or central line) placed within 24
hours of burn injury

3. Males and females

4. Ages >3 years or >15 kg

5. Informed verbal consent obtained from the patient or the patient's designated health
care proxy (DHCP). In the case of minors, assent and informed verbal consent obtained
from at least one parent or guardian.

Exclusion Criteria:

1. Known pre-existing hemostatic abnormalities

2. Ages < 3 years or weight < 15 kg

3. Intake of anticoagulants or antiplatelet aggregation inhibitors prior to burn

4. Pregnant patients

5. Patients with delayed presentation (greater than 24 hours after burn injury)

6. Inclusion in another clinical research study

7. Refusal or inability of patient or patient's DHCP to consent in English.