A randomized noninferiority crossover trial of corrected count increments and bleeding in thrombocytopenic hematology patients receiving 2‐ to 5‐ versus 6‐ or 7‐day–stored platelets

Abstract

BACKGROUND: Bacterial screening offers the possibility of extending platelet (PLT) storage to Day 7. We conducted a noninferiority, crossover trial comparing PLTs stored for 6 or 7 days versus 2 to 5 days. STUDY DESIGN AND METHODS: Stable hematology patients were allocated to receive blocks of 2-to 5-and 6-or 7-day PLTs in random order. The primary outcome was the proportion of successful transfusions during the first block, defined as a corrected count increment (CCI) of more than 4.5 at 8 to 24 hours posttransfusion. RESULTS: Of 122 patients with an evaluable first block, 87 (71%) and 84 (69%) had successful transfusions after 2-to 5-and 6-or 7-day PLTs of mean (SD) ages of 3.8 (1.0) and 6.4 (0.5) days, respectively. Six-or 7-day PLTs were declared noninferior to 2-to 5-day PLTs since the upper confidence interval (CI) limit was less than the predefined noninferiority margin of 10% (95% CI, 214.0% to 9.1%; p 5 0.766). Logistic regression analysis gave an adjusted odds ratio of 0.86 (95% CI, 0.47-1.58; p 5 0.625). Mean (SD) 8-to 24-hour CCIs were 9.4 (7.9) and 7.7 (7.1) after transfusion with 2-to 5-or 6-or 7-day PLTs (95% CI, 23.31 to 0.03; p 5 0.054). The proportions of days with bleeding scores of WHO Grade 2 or higher were 13% (38/297 days) and 11% (32/296 days; 95% CI, 23.2 to 7.2; p 5 0.454). Median interval to next PLT transfusion (2 days) was unaffected (95% CI, 210.5 to 5.4; p 5 0.531). CONCLUSION: In hematology patients, there was no evidence that 6-or 7-day PLTs were inferior to 2-to 5-day PLTs, as measured by proportion of patients with successful transfusions, bleeding events, or interval to next transfusion.

The quality of platelet concentrates related to corrected count increment: linking in vitro to in vivo

“…In line with literature, TEG measurements did not correlate with storage time, suggesting that this test is unable to monitor development of PSL and concomitant effects on 1‐hour CCIs. However, as CCI is a poor predictor of bleeding tendency, investigating the correlation between bleeding and product quality using TEG remains of interest.…”

“…The effectiveness of these prophylactic transfusions is usually monitored with the 1‐ and/or 24‐hour corrected count increment (CCI), which is the increase in circulating PLTs corrected for the administered dose and the blood volume of the patient. Despite being a poor surrogate marker for bleeding tendency, CCIs are associated with the time to next transfusions 5 and are therefore of clinical relevance.…”

Stored platelet number and viscoelastic maximum amplitude are not altered by warming or rapid infusion

“…We used platelets that were past their 5‐day clinical expiry date but less than 7 days old. Platelet concentrates are stored for only 5 days in the United States to limit bacterial overgrowth, but trials in humans show no difference in other laboratory or clinical outcomes between 5‐ and 7‐day platelets . Although platelets are stored at 22°C, ongoing trials of cold‐stored platelets may lead to a change in practice and increased risk of hypothermia.…”

Age of platelet concentrates and time to the next transfusion

“…Recently two published meta‐analyses showed that storage time plays an important role in the balance between efficacy, safety, and costs . Time to the next transfusion, as an outcome, was found to be reported in eight reviewed papers . Four of these studies could be meta‐analyzed and the interval between PLT transfusions after transfusion of old PLTs estimated to be 0.25 days (95% confidence interval [CI], 0.13‐0.38 days) shorter compared to transfusion of fresh PLTs …”

“…3,4 Time to the next transfusion, as an outcome, was found to be reported in eight reviewed papers. [5][6][7][8][9][10][11][12] Four of these studies could be meta-analyzed and the interval between PLT transfusions after transfusion of old PLTs estimated to be 0.25 days (95% confidence interval [CI], 0.13-0.38 days) shorter compared to transfusion of fresh PLTs. 3,[5][6][7][8] The influence of storage time on PLT recovery and survival could be affected by the type of PLT component transfused.…”