Abstract

BACKGROUND This pilot trial focused on feasibility and safety to provide preliminary data to evaluate the hemostatic potential of cold-stored platelets (2° to 6°C) compared with standard room temperature-stored platelets (20° to 24°C) in adult patients undergoing complex cardiothoracic surgery. This study aimed to assess feasibility and to provide information for future pivotal trials. METHODS A single center two-stage exploratory pilot study was performed on adult patients undergoing elective or semiurgent complex cardiothoracic surgery. In stage I, a two-armed randomized trial, platelets stored up to 7 days in the cold were compared with those stored at room temperature. In the subsequent single-arm stage II, cold storage time was extended to 8 to 14 days. The primary outcome was clinical effect measured by chest drain output. Secondary outcomes were platelet function measured by multiple electrode impedance aggregometry, total blood usage, immediate and long-term (28 days) adverse events, length of stay in intensive care, and mortality. RESULTS In stage I, the median chest drain output was 720 ml (quartiles 485 to 1,170, n = 25) in patients transfused with room temperature-stored platelets and 645 ml (quartiles 460 to 800, n = 25) in patients transfused with cold-stored platelets. No significant difference was observed. The difference in medians between the room temperature- and cold-stored up to 7 days arm was 75 ml (95% CI, -220, 425). In stage II, the median chest drain output was 690 ml (500 to 1,880, n = 15). The difference in medians between the room temperature arm and the nonconcurrent cold-stored 8 to 14 days arm was 30 ml (95% CI, -1,040, 355). Platelet aggregation in vitro increased after transfusion in both the room temperature- and cold-stored platelet study arms. Total blood usage, number of adverse events, length of stay in intensive care, and mortality were comparable among patients receiving cold-stored and room temperature-stored platelets. CONCLUSIONS This pilot trial supports the feasibility of platelets stored cold for up to 14 days and provides critical guidance for future pivotal trials in high-risk cardiothoracic bleeding patients.

Abstract

BACKGROUND The success of implementing Damage Control Resuscitation principles pre-hospital has been at the expense of several logistic burdens including the requirements for resupply, and the question of donor safety during the development of whole blood programs. Previous studies have reported effects on physical performance after blood donation, however none have investigated the effects of blood donation on cognitive performance. METHOD We describe a prospective double blinded, randomized controlled study comprised of a battery of tests: three cognitive tests, and VO2max testing on a cycle ergometer. Testing was performed 7 days before blinded donation (Baseline day), immediately after donation (Day 0), and 7 days (Day 7) after donation. The inclusion criteria included being active blood donors at the Haukeland University Hospital blood bank where eligibility requirements were met on the testing days and providing informed consent. Participants were randomized to either the experimental (n=26) or control group (n=31). Control group participants underwent a 'mock donation" in which a phlebotomy needle was placed but blood was not withdrawn. RESULTS In the experimental group, mean VO2max declined 6% from 41.35 +/-1.7 /(min.kg) at baseline to 39.0 +/-1.6 /(min.kg) on Day 0, and increased to 40.51 +/-1.5 /(min.kg) on Day 7. Comparable values in the control group were 42.1 +/-1.8 /(min.kg) at baseline, 41.6 +/-1.8 /(min.kg) on Day 1 (1% decline from basline), and 41.8 +/-1.8 /(min.kg) on Day 7.Comparing scores of all three cognitive tests on Day 0 and Day 7 showed no significant differences, p>0.05. CONCLUSION Our main findings are that executive cognitive and physical performance were well-maintained after whole blood donation in healthy blood donors. The findings inform post-donation guidance on when donors may be required to return to duty. LEVEL OF EVIDENCE I STUDY TYPE Randomized, controlled, double-blinded prospective trial.