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Comparison of the hemostatic efficacy of pathogen-reduced platelets vs untreated platelets in patients with thrombocytopenia and malignant hematologic diseases: a randomized clinical trial
Garban F, Guyard A, Labussiere H, Bulabois C E, Marchand T, Mounier C, Caillot D, Bay J O, Coiteux V, Schmidt-Tanguy A, et al
Jama Oncology. 2018;4((4):):468-475
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Abstract
Importance: Pathogen reduction of platelet concentrates may reduce transfusion-transmitted infections but is associated with qualitative impairment, which could have clinical significance with regard to platelet hemostatic capacity. Objective: To compare the effectiveness of platelets in additive solution treated with amotosalen-UV-A vs untreated platelets in plasma or in additive solution in patients with thrombocytopenia and hematologic malignancies. Design, Setting, and Participants: The Evaluation of the Efficacy of Platelets Treated With Pathogen Reduction Process (EFFIPAP) study was a randomized, noninferiority, 3-arm clinical trial performed from May 16, 2013, through January 21, 2016, at 13 French tertiary university hospitals. Clinical signs of bleeding were assessed daily until the end of aplasia, transfer to another department, need for a specific platelet product, or 30 days after enrollment. Consecutive adult patients with bone marrow aplasia, expected hospital stay of more than 10 days, and expected need of platelet transfusions were included. Interventions: At least 1 transfusion of platelets in additive solution with amotosalen-UV-A treatment, in plasma, or in additive solution. Main Outcomes and Measures: The proportion of patients with grade 2 or higher bleeding as defined by World Health Organization criteria. Results: Among 790 evaluable patients (mean [SD] age, 55 [13.4] years; 458 men [58.0%]), the primary end point was observed in 126 receiving pathogen-reduced platelets in additive solution (47.9%; 95% CI, 41.9%-54.0%), 114 receiving platelets in plasma (43.5%; 95% CI, 37.5%-49.5%), and 120 receiving platelets in additive solution (45.3%; 95% CI, 39.3%-51.3%). With a per-protocol population with a prespecified margin of 12.5%, noninferiority was not achieved when pathogen-reduced platelets in additive solution were compared with platelets in plasma (4.4%; 95% CI, -4.1% to 12.9%) but was achieved when the pathogen-reduced platelets were compared with platelets in additive solution (2.6%; 95% CI, -5.9% to 11.1%). The proportion of patients with grade 3 or 4 bleeding was not different among treatment arms. Conclusions and Relevance: Although the hemostatic efficacy of pathogen-reduced platelets in thrombopenic patients with hematologic malignancies was noninferior to platelets in additive solution, such noninferiority was not achieved when comparing pathogen-reduced platelets with platelets in plasma. Trial Registration: clinicaltrials.gov Identifier: NCT01789762.
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Effects of preoperative intentional hemodilution on the extravasation rate of albumin and fluid
Payen JF, Vuillez JP, Geoffray B, Lafond JL, Comet M, Stieglitz P, Jacquot C
Critical Care Medicine. 1997;25((2):):243-8.
Abstract
OBJECTIVE To evaluate the effects of preoperative intentional hemodilution with 4% albumin solution on the extravasation rate of intravascular albumin and fluid in surgical patients. DESIGN A prospective, randomized, clinical study. SETTING University teaching hospital. PATIENTS Two groups (control group [group 1] and hemodiluted group [group 2]) of 13 healthy patients were studied during a long-term (>4 hrs) surgical procedure. INTERVENTIONS Autologous technetium-99m (99mTc)-labeled red blood cells and indium-oxine ((111)In)-labeled human serum albumin were injected intravenously during anesthesia at T = 0 min in the two groups for the determination of total blood volume and albumin diffusion space, respectively. In addition, body tetrapolar electrical impedance was used to assess extracellular fluid volume. In the hemodiluted group (group 2), 15 mL/kg of blood was withdrawn over 30 mins (T = 20 mins to T = 50 mins) and simultaneously replaced by an equal volume of 4% albumin solution (0.6 g/kg). MEASUREMENTS AND MAIN RESULTS The albumin diffusion space, the colloid oncotic pressure, the plasma albumin concentration and the electrical impedance were measured before (T = 10 mins) and after (T = 60, 120, and 240 mins) hemodilution. Urine was collected from T = 10 mins to T = 240 mins. The total blood volume was calculated at T = 10 mins. No differences in the initial values were found between the two groups. In group 2, hemodilution (hematocrit 30 +/- 3%) resulted in a steeper increase in the albumin diffusion space (p < .05) and a progressive decrease in the body electrical impedance (p < .05). The extravasation rate of albumin was 0.052 +/- 0.007 mL/kg/min in group 2 vs. 0.038 +/- 0.020 mL/kg/min in group 1 (p < .05). The value of calculated plasma volume at T = 0 min did not shown any difference between the two groups. This value was then lower than expected in group 2, corresponding to a loss of plasma volume of >3 mL/kg. Urine output was significantly lower in group 2 than in group 1 (0.7 +/- 0.4 vs. 1.4 +/- 1.0 mL/min, respectively; p < .05). A comparable decrease in colloid oncotic pressure and in plasma albumin concentration was observed in both groups. CONCLUSIONS These results suggest that preoperative hemodilution using 4% albumin on a 1:1 volume basis for blood substitution during a prolonged surgical procedure with reduced blood losses enhances the extravasation rate of albumin and fluid to the interstitial tissues, impeding the maintenance of isovolemia. These findings support the use of a volume of infused colloid solution higher than that of withdrawn blood during preoperative hemodilution.