TY - JOUR
T1 - Hemostatic efficacy of pathogen-inactivated vs untreated platelets: a randomized controlled trial
AU - van der Meer, Pieter F.
AU - Ypma, Paula F.
AU - van Geloven, Nan
AU - van Hilten, Joost A.
AU - van Wordragen-Vlaswinkel, Rinie J.
AU - Eissen, Okke
AU - Zwaginga, Jaap J.
AU - Trus, Michael
AU - Beckers, Erik A. M.
AU - te Boekhorst, Peter
AU - Tinmouth, Alan
AU - Lin, Yulia
AU - Hsia, Cyrus
AU - Lee, David
AU - Norris, Philip J.
AU - Goodrich, Raymond P.
AU - Brand, Anneke
AU - Hervig, Tor
AU - Heddle, Nancy M.
AU - van der Bom, Johanna G.
AU - Kerkhoffs, Jean-Louis H.
PY - 2018/7/12
Y1 - 2018/7/12
N2 - Pathogen inactivation of platelet concentrates reduces the risk for blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen-inactivated platelets using riboflavin and UV B illumination technology (intervention) compared with standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion-treatment periods in which the patient had grade 2 or higher bleeding, as defined by World Health Organization criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion-treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade 2 or higher bleeding in the intention-to-treat analysis: 51% of the transfusion-treatment periods in the control arm and 54% in the intervention arm (95% confidence interval [CI], -6 to 11; P=.012 for noninferiority). However, in the per-protocol analysis, the difference in grade 2 or higher bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI22 to 18; P=.19 for noninferiority). Transfusion increment parameters were similar to 50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen-inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per-protocol analysis. This trial was registered at The Netherlands National Trial Registry as # NTR2106 and at www. clinicaltrials. gov as # NCT02783313.
AB - Pathogen inactivation of platelet concentrates reduces the risk for blood-borne infections. However, its effect on platelet function and hemostatic efficacy of transfusion is unclear. We conducted a randomized noninferiority trial comparing the efficacy of pathogen-inactivated platelets using riboflavin and UV B illumination technology (intervention) compared with standard plasma-stored platelets (control) for the prevention of bleeding in patients with hematologic malignancies and thrombocytopenia. The primary outcome parameter was the proportion of transfusion-treatment periods in which the patient had grade 2 or higher bleeding, as defined by World Health Organization criteria. Between November 2010 and April 2016, 469 unique patients were randomized to 567 transfusion-treatment periods (283 in the control arm, 284 in the intervention arm). There was a 3% absolute difference in grade 2 or higher bleeding in the intention-to-treat analysis: 51% of the transfusion-treatment periods in the control arm and 54% in the intervention arm (95% confidence interval [CI], -6 to 11; P=.012 for noninferiority). However, in the per-protocol analysis, the difference in grade 2 or higher bleeding was 8%: 44% in the control arm and 52% in the intervention arm (95% CI22 to 18; P=.19 for noninferiority). Transfusion increment parameters were similar to 50% lower in the intervention arm. There was no difference in the proportion of patients developing HLA class I alloantibodies. In conclusion, the noninferiority criterion for pathogen-inactivated platelets was met in the intention-to-treat analysis. This finding was not demonstrated in the per-protocol analysis. This trial was registered at The Netherlands National Trial Registry as # NTR2106 and at www. clinicaltrials. gov as # NCT02783313.
KW - WAVELENGTH ULTRAVIOLET-LIGHT
KW - BLOOD-CELL INACTIVATION
KW - PHOTOCHEMICAL TREATMENT
KW - ADDITIVE SOLUTION
KW - CLINICAL EFFECTIVENESS
KW - RIBOFLAVIN
KW - REDUCTION
KW - AMOTOSALEN
KW - TRANSFUSION
KW - BACTERIA
U2 - 10.1182/blood-2018-02-831289
DO - 10.1182/blood-2018-02-831289
M3 - Article
C2 - 29773572
SN - 0006-4971
VL - 132
SP - 223
EP - 231
JO - Blood
JF - Blood
IS - 2
ER -