Outcomes of patients enrolled in a prospective and randomized trial on basis of gestalt assessment or ABC score

Abstract

BACKGROUND The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial rapidly enrolled patients based on an Assessment of Blood Consumption (ABC) ≥ 2 score, or physician gestalt (PG) when ABC score was <2. The objective of this study was to describe what patients were enrolled by the two methods and whether patient outcomes differed based on these enrollments. We hypothesized that there would be no differences in outcomes based on whether patients were enrolled via ABC score or PG. METHODS Patients were enrolled with an ABC ≥ 2 or by PG when ABC was <2 by the attending trauma surgeon. We compared 1-hour, 3-hour, 6-hour, 12-hour, 18-hour, and 24-hour mortality, 30-day mortality, time to hemostasis, emergent surgical or interventional radiology procedure and the proportion of patients who required either >10 units of blood in 24 hours or >3 units in 1 hour. RESULTS Of 680 patients, 438 (64%) were enrolled on the basis of an ABC score ≥2 and 242 (36% by PG when the ABC score was <2). Patients enrolled by PG were older (median, 44; interquartile range [IQR], 28–59; p < 0.001), more likely to be White (70.3% vs. 60.3%, p = 0.014), and more likely to have been injured by blunt mechanisms (77.3% vs. 37.2%, p < 0.001). They were also less hypotensive and less tachycardic than patients enrolled by ABC score (both p < 0.001). The groups had similar Injury Severity Scores in the ABC ≥ 2 and PG groups (26 and 27, respectively) and were equally represented (49.1% and 50.8%, respectively) in the 1:1:1 treatment arm. There were no significant differences between the ABC score and PG groups for mortality at any point. Time to hemostasis (108 for patients enrolled on basis of Gestalt, vs. 100 minutes for patients enrolled on basis of ABC score), and the proportion of patients requiring a massive transfusion (>10 units/24 hours) (44.2% vs. 47.3%), or meeting the critical administration threshold (>3 unit/1 hour) (84.7% vs. 89.5%) were similar (p = 0.071) CONCLUSION Early identification of trauma patients likely to require a massive transfusion is important for clinical care, resource use, and selection of patients for clinical trials. Patients enrolled in the PROPPR trial based on PG when the ABC score was <2 represented 36% of the patients and had identical outcomes to those enrolled on the basis of an ABC score of ≥2. LEVEL OF EVIDENCE Prognostic and Epidemiological; Level III.