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.
BACKGROUND: Patients with prolonged neutropenia caused by chemotherapy or underlying marrow disorders are at risk of invasive bacterial and fungal infections. New treatment options alongside targeted antimicrobial therapy that might improve outcomes include granulocyte transfusions (GTX). To inform the research agenda, a prospective observational cohort study was performed in the Netherlands and United Kingdom. The aim was to describe the incidence, characteristics, and outcomes of patients developing invasive infections and assess patients fulfilling criteria for GTX. STUDY DESIGN AND METHODS: All patientsreceiving myeloablative chemotherapy and anticipated to develop 7 or more days of neutropenia (<0.5 × 10 9 /L) were eligible and followed for the development of invasive infections according to a defined algorithm and mortality up to 100 days. Secondary outcomes were types of infection and eligibility for GTX. RESULTS:A total of 471 patients enrolled at six hematology-oncology departments were followed for 569 neutropenic episodes. Overall, 32.5% of patients developed invasive infections during their first episode. Significant baseline risk factors for developing infections were high comorbidity scores (WHO performance status ≥ 2, hazard ratio [HR], 2.6 [1.7-3.9]; and hematopoietic cell transplantation-comorbidity index score ≥ 2 HR 1.3 [0.9-1.8]). Infections were bacterial (59.4%) and fungal (22.3%). Despite 34 patients (6.3% of all episodes) appearing to meet criteria to receive GTX, only nine patients received granulocytes. The HR for death was 5.8 (2.5-13.0) for patients with invasive infections. CONCLUSION:This study documents that invasive infections are associated with significant mortality. There is a need for new strategies to prevent and treat infections, which may include better understanding of use GTX. P atients with prolonged neutropenia caused by chemotherapy or underlying marrow disorders are vulnerable to infections caused by bacteria and fungi. These infections can cause direct morbidity and mortality, but in addition, patients who survive ABBREVIATIONS: AML = acute myeloid leukemia; GTX = granulocyte transfusions; HCT-CI = hematopoietic cell transplantation-comorbidity index; HR(s) = hazard ratio(s); MDS = myelodysplastic syndrome; SCT(s) = stem cell transplantation(s).From the
GASP has a similar safety profile to other sources of granulocytes for patients with refractory infection or in need of secondary prophylactic transfusion. Further studies are required to clarify the role of GASP in the treatment of neutropenic patients.
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