Acute cardiac care & resuscitationRandomised controlled trial

Cold and Room-Temperature Platelets in Cardiac Surgery

JAMAPublished

  • Randomised controlled trial
  • phase 3
  • multicentre
  • partially blinded
  • adaptive
  • non-inferiority
  • storage duration-ranging
  • 27 sites in the US and Australia

Authors' conclusion

For patients undergoing cardiac surgery, CSPs stored up to 21 days are noninferior to RTPs for the control of active surgical bleeding.

Study context

Population
Pediatric and adult patients undergoing cardiac surgery with planned cardiopulmonary bypass, actively bleeding989 in primary analysis
Participants
1,000 participants
Comparison
Cold-stored platelets vs room-temperature platelets
  • Cold-stored platelets (CSPs)n = 650
  • Room-temperature platelets (RTPs)n = 339reference
Primary endpoint
Hemostatic efficacy score (1 to 5; higher = greater bleeding); non-inferiority margin 1 point

Primary result

Hemostatic efficacy score

Mean difference

0.09

95% CrI −0.06 to 0.23

CSPs vs RTPs
mean difference 0.09 (95% CrI −0.06 to 0.23)

Non-inferiority margin 1 as printed, not drawn

As reported in the abstract

CSPs non-inferior to RTPs for all cold-storage durations; probability
>99.9%

Secondary outcomes

Median, mL/kg

OutcomeCSPsRTPsdifference in medians (95% CI)
Chest tube output · 24 hours · not statistically different8.9 (IQR 5.2–15.4)8.4 (IQR 5.5–15.9)0.4 (−1.0 to 1.5)

Mean

OutcomeCSPsRTPsEstimate
Hemostatic efficacy score, CSPs as single group (post hoc) · post hoc analysis3.08 (SD 1.15)2.99 (SD 1.10)

Safety

Thrombotic events, transfusion-associated AEs, ARDS, kidney failure, septic shock, mortality, reexploration

No differences in venous or arterial thrombotic events, transfusion-associated adverse events, ARDS, kidney failure, septic shock or mortality
Increased reexploration rates with CSPs

Original publication

Cold and Room-Temperature Platelets in Cardiac Surgery. JAMA. Published 17 August 2026. doi:10.1001/jama.2026.13328

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