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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.
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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4.
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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5.
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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6.
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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7.
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.
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8.
A randomized controlled trial comparing the frequency of acute reactions to plasma-removed platelets and prestorage WBC-reduced platelets
Heddle NM, Blajchman MA, Meyer RM, Lipton JH, Walker IR, Sher GD, Constantini LA, Patterson B, Roberts RS, Thorpe KE, et al
Transfusion. 2002;42((5):):556-66.
Abstract
BACKGROUND Removal of the plasma supernatant from platelets before transfusion is effective in preventing acute reactions to platelets caused by cytokines. Prestorage WBC reduction of platelets may be even more effective at preventing reactions as the WBCs are removed and WBC-derived cytokines do not accumulate in this component. This study evaluates the effectiveness of plasma removal and two methods of prestorage WBC reduction for preventing acute reactions to platelets. STUDY DESIGN AND METHODS Platelets given to adults with hematologic malignancies were randomly allocated to one of three types: plasma supernatant removed and a platelet storage solution added, whole blood-derived platelets that are prestorage WBC reduced by filtration before storage, and prestorage WBC-reduced apheresis platelets. Patients were monitored before, during, and after transfusion, and the severity of reactions was graded on a Likert scale. RESULTS A total of 129 patients from four centers were given 1190 platelet transfusions. The overall frequency of reactions was 13.6 percent (162 of 1190), 21.3 percent (36 of 169) for the plasma-removed platelets, 11.4 percent (59 of 517) for random donor WBC-reduced platelets, and 13.3 percent (67 of 504) for apheresis WBC-reduced platelets (p=0.384). The overall frequency of severe reactions was 4.1 percent with plasma-removed platelets, 1.7 percent for whole blood-derived, prestorage WBC-reduced platelets, and 1.4 percent for prestorage WBC-reduced apheresis platelets. CONCLUSION The frequency of reactions to plasma-removed platelets and prestorage WBC-reduced platelets was not significantly different; however, the power of the study for this comparison was low. There was no difference in the frequency of reactions to the two types of prestorage WBC-reduced platelets. The frequency of severe reactions to prestorage WBC-reduced platelets is low, occurring in only 1 to 2 percent of transfusions.
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9.
Comparison of post transfusion platelet response following random donor and apheresis platelets
Heddle NM, Blajchman MA, Sher G, Lipton J, Thorpe KK, Roberts R, Levine M
Transfusion. 2000;40((Suppl):):45S.. Abstract No. S168-040N.
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10.
A randomized trial comparing plasma removal to two types of pre-storage leukoreduction to prevent reactions to platelets
Heddle NM, Meyer R, Sher G, Walker I, Blajchman MA, Costantini L, Roberts R,, et al.,
Transfusion. 1999;39((S10):):96S.. Abstract No. S440-030P.