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Randomized Controlled Trial
. 2022 May 1;92(5):839-847.
doi: 10.1097/TA.0000000000003551. Epub 2022 Jan 25.

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

Frank X Guyette  1 , Mazen Zenati, Darrell J Triulzi, Mark H Yazer, Hunter Skroczky, Barbara J Early, Peter W Adams, Joshua B Brown, Louis Alarcon, Matthew D Neal, Raquel M Forsythe, Brian S Zuckerbraun, Andrew B Peitzman, Timothy R Billiar, Jason L Sperry
Affiliations
Randomized Controlled Trial

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

Frank X Guyette et al. J Trauma Acute Care Surg. .

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 remain limited.

Methods: We performed a single-center, prospective, cluster randomized, prehospital through 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 (systolic blood pressure ≤90 mm Hg and heart rate ≥108 beats per minute or systolic blood pressure ≤70 mm Hg 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-hour transfusion requirements, and arrival coagulation parameters.

Results: Between November 2018 and 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: Therapeutic/Care Management, Level II.

Trial registration: ClinicalTrials.gov NCT03477006.

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Conflict of interest statement

Conflicts of Interest: The authors have no conflicts of interest to declare

Figures

Figure 1.
Figure 1.
Screening, Randomization, and Follow-up.
Figure 2.
Figure 2.
Kaplan-Meier 28-day Survival Analysis; (Log-Rank Chi-Square test 0.034; p= 0.85)
See this image and copyright information in PMC

Comment in

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