A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology

Cazenave, J. P.; Folléa, Gilles; Bardiaux, L.; Boiron, Jean Michel; Lafeuillade, Bruno; Debost, M.; Lioure, Bruno; Harousseau, J L; Tabrizi, Robert; Cahn, Jean Yves; Michallet, M.; Ambruso, Daniel R.; Schots, Rik; Tissot, Jean‐Daniel; Sensebé, Luc; Kondo, Tosio; McCullough, Jeffrey; Rebulla, Paolo; Escolar, Ginés; Mintz, Paul D.; Heddle, Nancy M.; Goodrich, Raymond P.; Bruhwyler, Jacques; Le, Christina; Cook, Richard J.; Stouch, Brian

doi:10.1111/j.1537-2995.2010.02694.x

Cited by 147 publications

(159 citation statements)

References 55 publications

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“…Treatment often includes prednisone, infusions of intravenous immunoglobulin, and platelet transfusion [7]. Platelet transfusion, however, can lead to antibody responses in recipients, and as a result, there has been considerable research directed at the development of pathogeninactivated platelet products to reduce the risks of these reactions [8][9][10][11][12][13]. This article is concerned with methodological challenges arising in the design and analysis of randomized trials directed at comparing the effectiveness of standard and pathogen inactivated platelets.…”

Section: Platelet Transfusion Trials In Thrombocytopeniamentioning

confidence: 99%

“…Cazenave et al [11] report on a recent multicentre trial of 118 hematology/oncology patients with chemotherapy-induced thrombocytopenia who were randomized to receive either pathogen-inactivated platelets (Mirasol) or standard platelets as required over a 28 day treatment period. The primary outcome in this trial was the CCI with the posttransfusion platelet count measured 1 hour after transfusion.…”

Section: The Mirasol Trial Of Pathogen-inactived Plateletsmentioning

confidence: 99%

“…The primary analysis is based on comparing the probability of successful response between treatment arms under the implicit assumption that this probability does not change over time within treatment groups. Figure 1: Sample timeline plots of platelet transfusions and associated 1 h corrected count increments for four individuals from the Mirasol study [11] ; the horizontal line at 7500 is the threshold for defining successful responses to transfusion.…”

Section: The Mirasol Trial Of Pathogen-inactived Plateletsmentioning

confidence: 99%

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Inverse probability weighted estimating equations for randomized trials in transfusion medicine

Cook

Lee

Cuerden

et al. 2013

Statistics in Medicine

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SummaryThrombocytopenia is a condition characterized by extremely low platelet counts, which puts patients at elevated risk of morbidity and mortality because of bleeding. Trials in transfusion medicine are routinely designed to assess the effect of experimental platelet products on patients platelet counts. In such trials, patients may receive multiple platelet transfusions over a predefined period of treatment, and a response is available from each such administration. The resulting data comprised multiple responses per patient, and although it is natural to want to use this data in testing for treatment effects, naive analyses of the multiple responses can yield biased estimates of the probability of response and associated treatment effects. These biases arise because only subsets of the patients randomized contribute response data on the second and subsequent administrations of therapy and the balance between treatment groups with respect to potential confounding factors is lost. We discuss the design and analysis issues involved in this setting and make recommendations for the design of future platelet transfusion trials.

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Section: Platelet Transfusion Trials In Thrombocytopeniamentioning

confidence: 99%

Section: The Mirasol Trial Of Pathogen-inactived Plateletsmentioning

confidence: 99%

Section: The Mirasol Trial Of Pathogen-inactived Plateletsmentioning

confidence: 99%

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Inverse probability weighted estimating equations for randomized trials in transfusion medicine

Cook

Lee

Cuerden

et al. 2013

Statistics in Medicine

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“…The Mirasol Study (Cazenave et al, 2010) is a multicenter, open-label, parallel-group non-inferiority randomized controlled trial in which 118 haematology /oncology patients with thrombocytopenia were randomized to receive either a pathogen-reduced platelet product (PRT-PLT) (X = 1) or standard reference platelets (X = 0) as required over a 28-day treatment period (i.e. C A = 28).…”

Section: An Illustration Application To Data From the Mirasol Studymentioning

confidence: 99%

“…As a result, one might expect an association between the CCI for a particular transfusion and the time to the next transfusion. Figure 1: Profiles of four patients from the Mirasol Study (Cazenave et al, 2010) showing the times of the transfusions, the corrected count increments and the duration of follow-up; the horizontal line at 4.5 (×10 9 m 2 / ) is the threshold for a successful transfusion.…”

Section: Introductionmentioning

confidence: 99%

A copula model for marked point processes

2013

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SummaryMany chronic diseases feature recurring clinically important events. In addition, however, there often exists a random variable which is realized upon the occurrence of each event reflecting the severity of the event, a cost associated with it, or possibly a short term response indicating the effect of a therapeutic intervention. We describe a novel model for a marked point process which incorporates a dependence between continuous marks and the event process through the use of a copula function. The copula formulation ensures that event times can be modeled by any intensity function for point processes, and any multivariate model can be specified for the continuous marks. The relative efficiency of joint versus separate analyses of the event times and the marks is examined through simulation under random censoring. An application to data from a recent trial in transfusion medicine is given for illustration.

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Prophylactic platelet transfusion for prevention of bleeding in patients with haematological disorders after chemotherapy and stem cell transplantation

Estcourt

Stanworth

Dorée

et al. 2012

Cochrane Database of Systematic Reviews

139

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These conclusions refer to the four different types of platelet transfusion trial separately. Firstly, there is no evidence that a prophylactic platelet transfusion policy prevents bleeding. Two large trials comparing a therapeutic versus prophylactic platelet transfusion strategy, that have not yet been published, should provide important new data on this comparison. Secondly, there is no evidence, at the moment, to suggest a change from the current practice of using a platelet count of 10 x 10(9)/L. However, the evidence for a platelet count threshold of 10 x 10(9)/L being equivalent to 20 x 10(9)/L is not as definitive as it would first appear and further research is required. Thirdly, platelet dose does not affect the number of patients with significant bleeding, but whether it affects number of days each patient bleeds for is as yet undetermined. There is no evidence that platelet dose affects the incidence of WHO grade 4 bleeding.Prophylactic platelet transfusions were more effective than platelet-poor plasma at preventing bleeding.

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A randomized controlled clinical trial evaluating the performance and safety of platelets treated with MIRASOL pathogen reduction technology

Cited by 147 publications

References 55 publications

Inverse probability weighted estimating equations for randomized trials in transfusion medicine

Inverse probability weighted estimating equations for randomized trials in transfusion medicine

A copula model for marked point processes

Prophylactic platelet transfusion for prevention of bleeding in patients with haematological disorders after chemotherapy and stem cell transplantation

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