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• W2048804928 abstract "Background: INTERCEPT Platelets (IP) are prepared with Helinx® technology (amotosalen HCl and UVA) to inactivate a broad range of viruses, bacteria, and protozoa, as well as WBCs which can cause transfusion reactions and TA-GVHD. Methods: A double-blind, parallel group Phase III trial (SPRINT) randomized patients (pts) with malignancy undergoing chemotherapy only (CTX) (19%) or SCT (78%) to treatment with IP or Reference (RP) platelet (plt) transfusions (tx) for up to 28 days. The prophylactic tx threshold, selected by the treating physician, was 10×109/L in 61% and 20×109/L in 26% of pts. Results: 645 pts were tx’ed (318 IP vs 327 RP). The primary endpoint, equivalence of IP to RP in the control of moderate and severe (WHO Grade 2 and higher) bleeding, was demonstrated. Diagnosis (dx) and anti-neoplastic regimen (SCT vs CTX) were well balanced between IP and RP. 65% of SCT were autologous (auto) and 35% were allogeneic (allo); 70% were peripheral blood (PB) and 26% bone marrow (BM). 86% of PBSCT and 18% of BMT were auto. There were significant differences in dx, plt tx threshold, duration of plt support, no. of plt and RBC tx, and incidence and duration of Grade 2 or higher bleeding among auto SCT, allo SCT, and CTX pts (all p-values < 0.01). Leukemia was more common in allo than auto SCT; lymphoma, plasma cell dyscrasia, and solid tumor were more common in auto than allo SCT; acute leukemia was the most common dx for CTX pts (p < 0.001). Pts receiving auto SCT had the lowest tx threshold, shortest duration of plt support, fewest plt and RBC tx, and the lowest incidence and duration of Grade 2 or higher bleeding. Allo SCT were on the other extreme, and CTX pts were intermediate. No difference in incidence or duration of bleeding was observed between IP and RP for SCT pts. Conclusions: Allo SCT was associated with a longer duration of plt support, more plt and RBC tx, and a higher incidence and duration of significant bleeding than auto SCT or CTX. INTERCEPT Platelets were as effective as Reference platelets in control of Grade 2 and higher bleeding regardless of dx, anti-neoplastic tx, or stem cell source. TableStudy Endpoints for SCT PatientsEndpointAuto SCTAllo SCTIP (N = 154)RP (N = 171)P ValueIP (N = 86)RP (N = 91)P ValuePlt tx threshold 10× 109/L (%)70680.2948460.82Grade 2 bleeding (% pts)46510.4473741.00Grade 3/4 bleeding (% pts)020.259101.00Days of Grade 2 bleeding1.91.40.105.04.90.83Duration plt support (d)8.87.20.0516.816.70.88No. plt tx5.73.7<0.0114.011.30.07No. RBC tx3.42.70.046.16.60.58 Open table in a new tab" @default.
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• W2048804928 date "2004-02-01" @default.
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• W2048804928 title "Source of donor stem cells impacts incidence of bleeding and platelet and RBC transfusion requirements during stem cell transplantation (SCT): results of the phase III sprint trial of intercept pathogen inactivated platelets" @default.
• W2048804928 doi "https://doi.org/10.1016/j.bbmt.2003.12.166" @default.
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