Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial
Background—Cardiac surgery is frequently complicated by coagulopathic bleeding that is difficult to optimally manage using standard hemostatic testing. We hypothesized that point-of-care hemostatic testing within the context of an integrated transfusion algorithm would improve the management of coagulopathy in cardiac surgery and thereby reduce blood transfusions.
Methods—We conducted a pragmatic multi-centered stepped-wedge cluster randomized controlled trial of a POC-based transfusion algorithm in consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at 12 hospitals from Oct 6, 2014 to May 1, 2015. Following a 1-month data collection at all participating hospitals, a transfusion algorithm incorporating point-of-care hemostatic testing was sequentially implemented at 2 hospitals at a time in 1-month intervals, with the implementation order randomly assigned. No other aspects of care were modified. The primary outcome was red cell transfusion from surgery to postoperative day seven. Other outcomes included transfusion of other blood products, major bleeding, and major complications. The analysis adjusted for secular time-trends, within-hospital clustering, and patient-level risk factors. All outcomes and analyses were pre-specified before study initiation.
Results—Among the 7402 patients studied, 3555 underwent surgery during the control phase and 3847 during the intervention phase. Overall, 3329 (45.0%) received red cells, 1863 (25.2%) received platelets, 1645 (22.2%) received plasma, and 394 (5.3%) received cryoprecipitate. Major bleeding occurred in 1773 (24.1%) patients and major complications occurred in 740 (10.2%) patients. The trial intervention reduced rates of red cell transfusion (adjusted relative risk [RR], 0.91; 95% CI, 0.85 to 0.98; P = 0.02; Number needed to treat [NNT] 24.7), platelet transfusion (RR, 0.77; 95% CI, 0.68 to 0.87; P < 0.001; NNT 16.7), and major bleeding (RR, 0.83; 95% CI, 0.72 to 0.94; P = 0.004; NNT 22.6), but had no effect on other blood product transfusions or major complications.
Conclusions—Implementation of point-of-care hemostatic testing within the context of an integrated transfusion algorithm reduces red cell transfusions, platelet transfusions, and major bleeding following cardiac surgery. Our findings support the broader adoption of point-of-care hemostatic testing into clinical practice.
Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT02200419.
- Received June 10, 2016.
- Revision received August 10, 2016.
- Accepted September 2, 2016.