Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial

CirculationPublished Randomised controlled trial

Primary resultResult — go to the resultAdjusted relative risk 0.91 95% CI 0.85–0.98

Authors' conclusion

Implementation of point-of-care hemostatic testing within the context of an integrated transfusion algorithm reduces red blood cell transfusions, platelet transfusions, and major bleeding following cardiac surgery.

Study context

Population
Consecutive patients undergoing cardiac surgery with cardiopulmonary bypass at 12 hospitals, 2014–2015
Participants
7,402 patients · 12 hospitals
Comparison
Point-of-care-based transfusion algorithm vs standard hemostatic testing
  • Interventionn = 3,847
  • Controln = 3,555reference
Primary endpoint
Red blood cell transfusion
Follow-up
Surgery to postoperative day 7
Methodological detailspragmatic, multicentre, stepped-wedge cluster, All outcomes and analyses prespecified, Implementation order randomly assigned; 2 hospitals at a time in 1-month intervals
  • Pragmatic
  • Multicentre
  • Stepped-wedge cluster
  • All outcomes and analyses prespecified
  • Implementation order randomly assigned; 2 hospitals at a time in 1-month intervals

Primary result

As reported in the abstract

Adjusted relative risk

0.91

95% CI 0.85–0.98

P = 0.02

Intervention vs Control
adjusted RR 0.91 (95% CI 0.85–0.98); P = 0.02

Further findings

OutcomeRR (95% CI)P value
Platelet transfusionNNT 16.70.77 (0.68–0.87)P < 0.001

Other blood product transfusions

No effect on other blood product transfusions

Safety

OutcomeRR (95% CI)P value
Major bleedingNNT 22.60.83 (0.72–0.94)P = 0.004
  • Major bleeding: overall 1773 (24.1%) patients

Major complications

No effect on major complications
  • Overall 740 (10.2%) patients

Original publication

Point-of-Care Hemostatic Testing in Cardiac Surgery: A Stepped-Wedge Clustered Randomized Controlled Trial. Circulation. Published 21 September 2016. doi:10.1161/circulationaha.116.023956

Summarised from the published abstract; every number is checked against it

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