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Clinical efficacy and safety of platelets in additive solution treated with two commercial pathogen reduction technologies
Rebulla P, Vaglio S, Aprili G, Beccaria F, Coluzzi S, Girelli G, Graf M, Isernia P, Marconi M, Olivero B, et al
Transfusion. 2015;55((Suppl. 3)):3A.. Abstract no. P2-030A.
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2.
A randomized controlled trial comparing standard- and low-dose strategies for transfusion of platelets (SToP) to patients with thrombocytopenia
Heddle NM, Cook RJ, Tinmouth A, Kouroukis CT, Hervig T, Klapper E, Brandwein JM, Szczepiorkowski ZM, AuBuchon JP, Barty RL, et al
Blood. 2009;113((7):):1564-73.
Abstract
A noninferiority study was performed comparing low-dose and standard-dose prophylactic platelet transfusions. A double-blind randomized controlled trial (RCT) was performed in 6 sites in 3 countries. Thrombocytopenic adults requiring prophylactic platelet transfusion were randomly allocated to standard-dose (300-600 x 10(9) platelets/product) or low-dose (150- < 300 x 10(9) platelets/product) platelets. The primary outcome (World Health Organization [WHO] bleeding > or = grade 2) was assessed daily through clinical examination, patient interview, and chart review. A WHO grade was assigned through adjudication. The Data Safety Monitoring Board stopped the study because the difference in the grade 4 bleeding reached the prespecified threshold of 5%. At this time, 129 patients had been randomized and 119 patients were included in the analysis (58 low dose; 61 standard dose). Three patients in the low-dose arm (5. 2%) had grade 4 bleeds compared with none in the standard-dose arm. WHO bleeding grade 2 or higher was 49. 2% (30/61) in the standard-dose arm and 51. 7% (30/58) in the low-dose group (relative risk [RR], 1. 052; 95% confidence interval [CI], 0. 737-1. 502). A higher rate of grade 4 bleeding in patients receiving low-dose prophylactic platelet transfusions resulted in this RCT being stopped. Whether this finding was due to chance or represents a real difference requires further investigation. These clinical studies are registered on (http://www. clinicaltrials. gov) as NCT00420914.
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3.
Comparing the efficacy and safety of apheresis and whole blood-derived platelet transfusions: a systematic review
Heddle NM, Arnold DM, Boye D, Webert KE, Resz I, Dumont LJ
Transfusion. 2008;48((7):):1447-58.
Abstract
BACKGROUND A systematic review and meta-analysis was performed to determine if there were differences between apheresis platelet concentrates (APCs) or platelets (PLTs) derived from whole blood (WBD) for the outcomes acute reactions, alloimmunization, refractoriness, corrected count increment (CCI), radiolabeled recovery and survival, time to next transfusion, and bleeding. STUDY DESIGN AND METHODS We searched Medline, Embase, the Cochrane Registry of Controlled Trials, PapersFirst, ProceedingsFirst, and AABB and ASH abstracts for randomized controlled trials (RCTs) comparing APCs and WBD PLTs for clinical outcomes. Study selection, data extraction, and methodologic quality assessments were performed in duplicate. Results were pooled using meta-analytic methods. RESULTS Ten RCTs met the inclusion criteria. Acute reactions per patient were lower for APCs (relative risk [RR], 0.65; 95% CI, 0.44-0.98); however, when controlling for leukoreduction, there was no significant difference (leukoreduced [LR]-APCs vs. LR-WBDs; odds ratio, 1.78; 95% CI, 0.87-3.62). There was no difference between products when reaction frequencies were assessed per transfusion (RR, 0.65; 95% CI, 0.33-1.28). APCs were associated with significantly higher CCIs than WBD PLTs at both 1 hour (weighted mean difference [WMD], 2.49; 95% CI, 2.21-2.77) and 18 to 24 hours (WMD, 1.64; 95% CI, 0.60-2.67). No conclusions could be made for the outcomes of alloimmunization and refractoriness. No studies addressed outcomes of time to next transfusion or bleeding. CONCLUSIONS Owing to the small number of trials and lack of comparability of PLT products for leukoreduction, we were unable to draw definitive conclusions about the clinical benefits of APCs compared with WBD PLTs. Rigorous RCTs using clinically important end points are needed to settle this issue.
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4.
A systematic review and meta-analysis of platelets prepared from apheresis versus whole blood
Heddle NM, Arnold DM, Dumont LJ, Boye D, Webert KE
Transfusion. 2007;47((Suppl 3):):192-3A.. Abstract No. SP442
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5.
Assessing the effectiveness of whole blood-derived platelets stored as a pool: a randomized block noninferiority trial
Heddle NM, Cook RJ, Blajchman MA, Barty RL, Sigouin CS, Boye DM, Nelson EJ, Kelton JG
Transfusion. 2005;45((6):):896-903.
Abstract
BACKGROUND Prestorage pooling of whole blood-derived platelets (PLTs) would simplify bacterial detection. This study evaluated the in vivo effect of the prestorage pooling of PLTs stored for up to 5 days, by assessing the corrected count increment (CCI) 18 to 24 hours after transfusion of the product. STUDY DESIGN AND METHODS A randomized block noninferiority design was used. Eligible patients had chemotherapy-induced thrombocytopenia and were considered likely to need at least six PLT transfusions. For every block of two transfusion events, one consisted of PLTs stored individually and then pooled before transfusion, and the other was a product pooled before storage. The primary outcome was categorized as a successful (>4. 5) or unsuccessful ( RESULTS Twenty-three eligible patients received a total of 189 PLT transfusions. The median number of PLT transfusions was 7 (range, 0-27). Eighty-five complete transfusion pairs were used in the primary analysis. The proportions of transfusions leading to a CCI of greater than 4. 5 was identical for both routine and PLTs pooled before storage (45/85=52. 9%; relative risk, 1. 00; lower limit of the one-sided 95% confidence interval [CI], 0. 83). The estimate of the mean difference in CCI between pooled and routine storage (pooled-routine) was -0. 45 (95% CI, -2. 23 to 1. 33; p=0. 63). CONCLUSION These results provide evidence that storage of PLTs as a pool for up to 5 days results in posttransfusion CCIs that are not inferior to PLTs stored individually.
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6.
A randomized crossover trial comparing in-vivo platelet recovery and survival of leukoreduced apheresis and whole blood derived platelets
Arnold DM, Heddle NM, Carruthers J, Kulczycky M, Sigouin C, Blajchman MA
Transfusion. 2004;44((s1):):1A.. Abstract No. P2-030A.
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7.
Whole blood derived platelets stored as a pool: a randomized block non-inferiority study
Heddle NM, Cook RJ, Barty R, Sigouin C, Boye D, Blajchman MA, Nelson E, Kelton JG
Vox Sanguinis. 2004;87((Suppl 3):):6. Abstract No. M 14. 05.
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8.
Comparison of methods for the analysis of bleeding outcomes in platelet transfusion studies
Cook RJ, Heddle NM, Rebulla P, Sigouin C, Webert K
Transfusion. 2003;43((9S):):31A.. Abstract No. S102-040F.
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9.
Methodologic issues in the use of bleeding as an outcome in transfusion medicine studies
Heddle NM, Cook RJ, Webert KE, Sigouin C, Rebulla P
Transfusion. 2003;43((6):):742-752.
Abstract
BACKGROUND Prophylactic platelet transfusions are given to thrombocytopenic patients to prevent bleeding. The benefit of platelet transfusions has frequently been assessed by measuring the count increment; however, more recently, an assessment of bleeding has been used because it is a more clinically relevant outcome measure. The purpose of this study was to identify platelet transfusion trigger studies that used bleeding as an outcome measure, compare and contrast methods used to document bleeding and analyze bleeding outcomes, and identify and discuss methodologic issues to consider when bleeding is used as a study outcome. STUDY DESIGN AND METHODS A systematic search to identify platelet transfusion trigger studies was performed. Relevant articles were reviewed to identify how bleeding data was captured and analyzed, and methodologic considerations were identified. RESULTS Seven articles meeting the predefined entry criteria were identified. Methods used to document bleeding included chart review and clinical assessment. The frequency of assessment and the type of personnel performing the assessment were variable. Four approaches to analysis were identified: descriptive; comparison of the proportions of patients having at least one bleed; comparison of patient days with bleeding expressed as a proportion of the total days at risk of bleeding; and time-to-event (first bleed) analysis. CONCLUSION Methodologic issues for consideration when designing a clinical study with bleeding as the outcome measure included approaches to minimize bias in the documentation and classification of bleeding and selection of an analysis approach that is appropriate to the question being asked. The need for development of a valid and reliable bleeding scale was also identified.
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10.
Platelet transfusions in children: results of a randomized, prospective, crossover trial of plasma removal and a prospective audit of WBC reduction
Couban S, Carruthers J, Andreou P, Klama LN, Barr R, Kelton JG, Heddle NM
Transfusion. 2002;42((6):):753-8.
Abstract
BACKGROUND Febrile nonhemolytic transfusion reactions (FNHTRs) complicate 2 to 37 percent of platelet transfusions in adults, but the incidence of such reactions in children is not known. The effectiveness of plasma reduction after storage and WBC reduction of platelet concentrates before storage was studied in pediatric recipients of platelet transfusions. STUDY DESIGN AND METHODS In the first study, a prospective randomized crossover design was used in which patients received either unmodified whole-blood-derived or apheresis platelets or platelets from which most of the plasma supernatant had been removed just before transfusion. The second study was a prospective audit of recipients of prestorage WBC-reduced platelets. Children between 3 months and 17 years of age were eligible for both studies. Patients were assessed for signs and symptoms that are characteristic of a reaction during, immediately after, and 2 hours following transfusion. RESULTS There were 226 platelet transfusions administered to 66 children. One hundred and sixty transfusions were given to 35 children enrolled in the randomized study, and 66 transfusions were given to 33 children during the audit. In the randomized study, nine of the 75 transfusions of unmodified platelets (12%) and six of 85 transfusions of poststorage plasma-removed platelets (7%) were associated with an FNHTR (p=0.42). In the audit, three of 66 transfusions of prestorage WBC-reduced platelets (5%) were associated with an FNHTR. Allergic reactions occurred with 5 percent (4 of 75), 6 percent (5 of 85), and 6 percent (4 of 66) of platelet transfusions, respectively. CONCLUSION FNHTRs appear to be less common among pediatric recipients of platelet transfusions than in adults. In our two studies, there was a trend toward a lower frequency of FNHTRs with poststorage plasma removal and prestorage WBC reduction than with standard platelets, but this was not significant.