<p>Pooled Platelet Concentrate in India was approved in the 2020 amendment of the Drugs and Cosmetics Act. This study was done to determine whether pooled platelets can be an alternative to apheresis-derived platelet concentrates in hemato-oncology patients. This was a non-randomized crossover study that included 35 adult hemato-oncology patients who received both products. In vitro quality parameters were compared at day 1 and day 5 of storage. The in vivo effectiveness was compared in terms of platelet increment (PI), Corrected Count Increment (CCI), and Percentage Platelet Recovery (PPR) at 1&#xa0;h and 24&#xa0;h post-transfusion. The products were comparable across all hematological and biochemical quality parameters except glucose and lactate concentrations, which were significantly higher in BCPP at day 1 of storage, with no significant difference at day 5. The drop in pH was greater in AP-PC than in BCPP, but within acceptable limits. No statistically significant difference was observed in PI, CCI, and PPR between the two products at any time point. BCPP is comparable to AP-PC in terms of in vitro quality and in vivo effectiveness and can be used safely in hemato-oncology patients.</p><p><b>Trial Registration</b> The trial was registered prospectively in Clinical Trial Registry-India (CTRI) (vide registration no. CTRI/2022/12/047874).</p>

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Buffy Coat Pooled Platelets Versus Apheresis Platelets in Indian Hemato-Oncology Patients: A Non-Randomized Crossover Trial

  • Juhi Bhatia,
  • Ashish Jain,
  • Gita Negi,
  • Daljit Kaur,
  • Gaurav Dhingra,
  • Reshma Benson,
  • Uttam Kumar Nath

摘要

Pooled Platelet Concentrate in India was approved in the 2020 amendment of the Drugs and Cosmetics Act. This study was done to determine whether pooled platelets can be an alternative to apheresis-derived platelet concentrates in hemato-oncology patients. This was a non-randomized crossover study that included 35 adult hemato-oncology patients who received both products. In vitro quality parameters were compared at day 1 and day 5 of storage. The in vivo effectiveness was compared in terms of platelet increment (PI), Corrected Count Increment (CCI), and Percentage Platelet Recovery (PPR) at 1 h and 24 h post-transfusion. The products were comparable across all hematological and biochemical quality parameters except glucose and lactate concentrations, which were significantly higher in BCPP at day 1 of storage, with no significant difference at day 5. The drop in pH was greater in AP-PC than in BCPP, but within acceptable limits. No statistically significant difference was observed in PI, CCI, and PPR between the two products at any time point. BCPP is comparable to AP-PC in terms of in vitro quality and in vivo effectiveness and can be used safely in hemato-oncology patients.

Trial Registration The trial was registered prospectively in Clinical Trial Registry-India (CTRI) (vide registration no. CTRI/2022/12/047874).