Prehospital low titer group O whole blood is feasible and safe: Results of a prospective randomized pilot trial

Department of Emergency Medicine, University of Pittsburgh, Pittsburgh, PA Department of Surgery, University of Pittsburgh, Pittsburgh, PA Department of Pathology and Institute for Transfusion Medicine, University of Pittsburgh, Pittsburgh, PA Department of Critical Care Medicine, University of Pittsburgh, Pittsburgh, PA.

The journal of trauma and acute care surgery. 2022
PICO Summary

Population

Injured air medical patients (n= 86).

Intervention

Pre-hospital and in-hospital low titre group O whole blood (LTOWB) resuscitation (n= 40).

Comparison

Standard pre-hospital air medical care including red cell transfusion and crystalloids followed by in-hospital component transfusion (n= 46).

Outcome

Patients randomized to pre-hospital LTOWB relative to standard care had lower red cell transfusion requirements at 24 hours, and a lower incidence of abnormal thromboelastographic measurements. No transfusion reactions during the pre-hospital or in-hospital phase of care were documented.
Abstract
INTRODUCTION Low titer group O whole blood (LTOWB) resuscitation is increasingly common in both military and civilian settings. Data regarding the safety and efficacy of prehospital LTOWB remains limited. METHODS We performed a single center, prospective, cluster randomized, prehospital thru in-hospital whole blood pilot trial for injured air medical patients. We compared standard prehospital air medical care including red cell transfusion and crystalloids followed by in-hospital component transfusion to prehospital and in-hospital LTOWB resuscitation. Prehospital vital signs were used as inclusion criteria (SBP ≤ 90 mmHg and HR ≥ 108 bpm) or (SBP ≤ 70 mmHg) for patients at risk of hemorrhage. Primary outcome was feasibility. Secondary outcomes included 28-day and 24 hour mortality, multiple organ failure, nosocomial infection, 24 hr transfusion requirements and arrival coagulation parameters. RESULTS Between November 2018 thru October 2020, 86 injured patients were cluster randomized by helicopter base. The trial has halted early at 77% enrollment. Overall, 28-day mortality for the cohort was 26%. Injured patients randomized to prehospital LTOWB (n = 40) relative to standard care (n = 46) were similar in demographics and injury characteristics. Intent to treat Kaplan-Meier survival analysis demonstrated no statistical mortality benefit at 28 days (25.0% vs. 26.1%, p = 0.85). Patients randomized to prehospital LTOWB relative to standard care had lower red cell transfusion requirements at 24 hours (p < 0.01) and a lower incidence of abnormal thromboelastographic measurements. No transfusion reactions during the prehospital or in-hospital phase of care were documented. CONCLUSION Prehospital through in-hospital LTOWB resuscitation is safe and may be associated with hemostatic benefits. A large-scale clinical trial is feasible with protocol adjustment and would allow the effects of prehospital LTOWB on survival and other pertinent clinical outcomes to be appropriately characterized. LEVEL OF EVIDENCE II, Cluster randomized pilot trial.
Study details
Language : eng
Additional Material : Commentary in: ‘The Journal of Trauma and Acute Care Surgery’ (2022), PMID: 35696382, DOI: <a href="http://dx.doi.org/10.1097/TA.0000000000003686">http://dx.doi.org/10.1097/TA.0000000000003686</a>
Credits : Bibliographic data from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine