Design and preliminary results of a pilot randomized controlled trial on a 1:1:1 transfusion strategy: the trauma formula-driven versus laboratory-guided study

Abstract

Background: Retrospective reviews have recently shown an survival benefit for adopting a resuscitation strategy that transfuses plasma and platelets at a near 1:1 ratio with red blood cells (RBCs). However, a randomized controlled trial on the topic is lacking. We report on the design and preliminary results of our ongoing randomized control pilot trial (ClinicalTrial.gov NCT00945542).

Methods: This is a 2-year feasibility randomized control trial at a single tertiary trauma center. Bleeding trauma patients were randomized to either a laboratory-driven or a formula-driven (1 plasma:1 platelet:1 RBC) transfusion protocols. Feasibility was assessed by analyzing for ability to enroll patients, appropriate activation of transfusion protocols, time to transfusion of each type of blood product, laboratory turnaround time, ratio of blood products transfused, and wastage of blood products.

Results: From July 6, 2009, to May 31, 2010, n = 18 patients were randomized and included in the study. Issues that we noted were the need to do postrandomization exclusions, the need to have rapid and accurate predictors of massive bleeding to enroll patients quickly, and the need to have waived consent for study participation. As well, we noted that the logistics of administering 1:1:1 were formidable and required rapid access to thawed plasma. Similarly, challenges in the control arm of such a study included the turnaround time for obtaining laboratory results.

Conclusion: Despite major challenges, our initial experience suggests that with an organized system, it is possible to prospectively randomize massively bleeding trauma patients. The accomplishment of high ratios of plasma to RBCs is challenging with current thawing methods and unavailability of thawed plasma in Canada. Longer shelf-life for plasma and faster plasma thawing microwaves should overcome some of these obstacles. For a laboratory-guided transfusion protocol, massive transfusion protocols should be in place with faster turnaround time for coagulation tests. Finally, further research on predictors of massive transfusion is needed.