WTA SHED THORACIC BLOOD STUDY PROTOCOL FINAL

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A PROSPECTIVE MULTICENTER EVALUATION OF THE TRANSFUSION OF SHED THORACIC BLOOD IN
TRAUMA
A WTA MULTICENTER TRIAL
Gary Vercruysse, MD and Peter Rhee, MD
Department of Surgery, Division of Acute Care, Trauma, Critical Care and Burns
University of Arizona Medical Center
Contact email:
gvercruysse@surgery.arizona.edu
Background
Hemothorax or Hemopneumothorax occurs relatively frequently after blunt and penetrating thoracic
trauma. Since the mid 20th century, shed blood from closed suction chest tube collection devices has
been routinely reinfused as a part of resuscitation with significant success.1,2,3 Historically, coagulation
parameters measured in this shed blood find it to be lacking in fibrin (23 mg/100ml), and exceedingly
coagulopathic with an INR > 9.1,4 The result of this combination of factors may lead to clinical
coagulopathy that may increase the number of transfusions required to correct this induced
coagulopathy and negatively affect patient outcomes. In addition, significant concern exists that the
heparin used in collection devices (if used instead of citrate) may lead to acute lung injury caused by
heparin activated (primed) platelets.5 The converse of these arguments is that blood component
transfusion has been associated with an increased risk of acute respiratory distress syndrome,
pneumonia, transfusion associated lung injury, and exposure to blood-borne pathogens.6 However,
none of these hypotheses have been proven in clinical situations with modern coagulation studies.
The purpose of this study is therefore to prospectively evaluate the baseline coagulation parameters of
patients suffering thoracic trauma and hemo or hemopneumothorax. In addition, we will study the
coagulation parameters of patients who have and have not received shed thoracic blood both before
and after transfusion and their overall transfusion requirement in a WTA multicenter observational
study.
Primary Outcome Measure
Number of units of PRBC’s received by victims of thoracic trauma in the first 48 hours after hospital
admission.
Secondary Outcome Measures
Coagulopathy (defined as INR>1.7) measured at any point in the first 48 hours after hospital admission.
Number of units of fresh frozen plasma, platelets, and cryoprecipitate, amount of blood retransfused
from collection device, amount of Prothrombin Complex and/or TXA received in the first 48 hours after
hospital admission.
Study Design
This is a prospective multicenter observational study. All adult patients (≥18 years old) who have
sustained blunt or penetrating chest trauma requiring thorocostomy tube drainage for hemothorax or
hemopneumothorax will be included in the study. All patients will undergo a routine workup and
clinical care as is standard at the institution in which they reside. As part of routine care, all patients will
undergo standard coagulation testing followed through to discharge with prospective abstraction of the
data points listed below on the data collection form. A sample of shed thoracic blood will also be sent
for coagulation testing prior to reinfusion or discard. The study will be observational. All patient care
decisions will be made by the treating physicians without input from the research team. Inclusion in the
study will in no way impact the patient’s care. Trauma registry data will be utilized to capture
demographic data.
-
Demographics
Mechanism of Injury
Admission GCS and vital signs
Initial Base deficit and Serum Lactate
-
Chest AIS
Associated injuries
Thoracic complications
Clinical complications attributed to coagulopathy
Medications
Results of the baseline and later coagulation parameters (including TEG if used at institution)
Coagulation Parameters of Shed Thoracic Blood
Operative Procedures Performed
Blood Product Requirement in First 48 hrs
Development of Acute Lung Injury/TRALI/DVT
Final diagnosis at time of discharge
Outcome at the time of discharge
Statistical Analysis
A descriptive analysis will be performed using means and standard deviations for continuous variables
and percentages for categorical variables. Students t-test or Mann-Whitney U test will be used to
explore group differences in the number of blood products transfused. A X2 analysis will be performed
to explore differences in coagulopathy between groups. A regression analysis will be performed to
identify significant predictors for the need for blood transfusion.
Consent Procedures
This is a prospective observational study. No intervention will be performed and no change in patient
management will occur as a result of participation in this study. All data will be stored in a secure
database without patient identifiers.
References
1
Symbas, PN, Levin, JM, Ferrier, FL et al. A Study On Autotransfusion From Hemothorax. Sothern Medical Journal
1969;62: 671-4.
2
Symbas, PN. Autotransfusion From Hemothorax: Experimental and Clinical Studies. The Journal of Trauma
1972;12(8): 689-95.
3
Von Hippel, A. Autotransfusion Of Major Hemothorax In A Simple Country Hospital. Alaska Medicine
1975;17(4):62-3.
4
Salhanick, M, Corneille, M, Higgins, R, et al. Autotransfusion Of Hemothorax Blood In Trauma Patients: Is It The
Same As Fresh Whole Blood? The American Journal of Surgery 2011;202:817-22.
5
Harr, JN, Moore, EE, Wohlauer, MV, et al. Activated Platelets In Heparinized Shed Blood: The “Second-Hit” Of
Acute Lung Injury In Trauma/Hemorrhagic Shock Models. Shock 2011;36: 595-603.
6
Napolitano LM, Kurek S, Luchette FA, et al. Clinical Practice Guideline: Red Blood Cell Transfusion In Adult
Trauma And Critical Care. The Journal of Trauma 2009;67:1439-42.
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