Single Institution Trial Comparing Whole Blood vs Balanced Component Therapy: 50 Years Later

Abstract

BACKGROUND: Early close ratio transfusion with balanced component therapy (BCT) has been associated with improved outcomes in patients with severe hemorrhage; however, this modality is not comparable with whole blood (WB) constituents. We compared use of BCT vs WB to determine if one yielded superior outcomes in patients with severe hemorrhage. We hypothesized that WB would lead to reduced in-hospital mortality and blood product volume if given in the first 24 hours of admission. STUDY DESIGN: This was a 1-year, single institution, prospective, observational study comparing BCT with WB in adult (18þy) trauma patients with active hemorrhage who required blood transfusion upon arrival at the emergency department. Primary endpoint was in-hospital mortality. Secondary endpoints included 24-hour transfusion volumes, in-hospital clinical outcomes, and complications. RESULTS:A total of 253 patients were included; 71.1% received BCT and 29.9% WB. The WB cohort had significantly more penetrating trauma (64.4% vs 48.9%; p ¼ 0.03) and higher Shock Index (1.12 vs 0.92; p ¼ 0.04). WB patients received significantly fewer units of packed red blood cells (PRBCs) (p < 0.001) and fresh frozen plasma (FFP) (p ¼ 0.04), with a lower incidence of ARDS (p ¼ 0.03) and fewer ventilator days (p ¼ 0.03). Kaplan Meier survival analysis revealed no difference in survival between the 2 transfusion strategies (p ¼ 0.80). When adjusted for various markers of injury severity and critical illness in Cox regression analysis, WB remained unassociated with mortality (hazard ratio 1.25; 95% CI 0.60e2.58; p ¼ 0.55). CONCLUSIONS: There was no difference in survival rates when comparing BCT with WB. In the WB group, the incidence of ARDS, duration of mechanical ventilation, massive transfusion protocol (MTP) activation, and transfusion volumes were significantly reduced. Further research should be directed at analyzing whether there is a true hemorrhage-related pathophysiologic benefit of WB when compared with BCT.

Survey of group A plasma and low‐titer group O whole blood use in trauma resuscitation at adult civilian level 1 trauma centers in the US

“…It is interesting that 51% of the centers that use LTOWB would administer RhD‐positive LTOWB to females of childbearing potential whose RhD‐type is either negative or unknown at the time of the transfusion. Perhaps this reflects the adoption of the findings of studies that demonstrated a survival benefit when blood products were administered early in the resuscitation, 6–9 that there are emerging data showing some benefits of transfusing LTOWB, 21–24 and a recognition that hemolytic disease of the fetus and newborn, while still a stressful and emotionally draining diagnosis, is now largely a manageable condition in many parts of the world 25–28 …”

Injured recipients of low‐titer group O whole blood have similar clinical outcomes compared to recipients of conventional component therapy: A single‐center, retrospective study

“…Several studies have analyzed the frequency of occurrence of clinical outcomes other than mortality following LTOWB transfusion in trauma patients. In two studies, receipt of a median (IQR) of 1 (1–1) and 2 (1–3) LTOWB units, respectively, 12,13 was associated with either no difference in the frequencies of the measured clinical events, or in some cases significantly reduced major complications, such as acute kidney injury, acute respiratory distress syndrome (ARDS), deep vein thrombosis/pulmonary embolism, cardiac arrest, pneumonia, sepsis etc. compared to recipients of CCT.…”

“…Initially, the data that were generated on the use of LTOWB surrounded implementation strategies in the pre‐hospital and in‐hospital phases of the resuscitation, 1–3 as well as data on the serological safety of transfusing LTOWB to non‐group‐O recipients 4–6 . As the use of LTOWB began to increase in the US and in other countries, 7–9 several studies have attempted to determine whether the use of LTOWB in trauma resuscitation resulted in a survival benefit compared with the transfusion of conventional components (CCT) using different study methodologies and have found conflicting results 10–15 . For example, in a single‐center analysis of 198 injured LTOWB patients who received a median of one unit either pre‐hospital or early in their in‐hospital course, 30‐day mortality was reduced in a multivariate logistic regression model compared to 152 conventional component recipients 11 .…”

“…A multivariate analysis performed on the American College of Surgeons Trauma Quality Improvement Program (TQIP) database during the calendar years of 2015 and 2016 also revealed that 24‐h and in‐hospital mortality was significantly reduced among the 280 patients who had received a median (IQR) of 1 (1–1) unit LTOWB compared to 8214 patients who received only component therapy 12 . Conversely, three other observational single‐center studies in which the LTOWB patients received a median (IQR) of 2 (1–3), 6.5 (3–11), and 2 (1–2) units of LTOWB, respectively, 13–15 did not demonstrate a mortality benefit compared to the patients who received CCT. A recent meta‐analysis of studies reporting 24‐h and 30‐day/in‐hospital survival among LTOWB recipients compared to those resuscitated with conventional components also did not find a survival advantage to the receipt of LTOWB 16 .…”

Whole blood for trauma patients: Outcomes at higher doses

“…There have been multiple studies comparing LTOWB to component therapy that have sought to demonstrate the potential benefits of LTOWB with varying results. These studies have used different methodologies and varying doses of WB 10‐15 . A 2020 review of WB studies concluded that there is substantial evidence that WB is safe and feasible, but it has not been shown to be superior to component therapy in any large or randomized studies 16 .…”