A PROSPECTIVE MULTICENTER EVALUATION OF THE TRANSFUSION OF SHED THORACIC BLOOD IN TRAUMA
A WTA MULTICENTER TRIAL
Gary Vercruysse, MD andPeter Rhee, MD
Department of Surgery, Division of Acute Care, Trauma, Critical Care and Burns
University of Arizona Medical Center
Contact email:
Background
Hemothoraxor Hemopneumothorax occurs relativelyfrequently after bluntand 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 INR1.7) 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 hemopneumothoraxwill be included in the study. All patients will undergoa routine workup and clinical careas 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.