Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial
Background: Citrate-related hypocalcemia is the most common adverse event linked with peripheral blood progenitor cell apheresis. A previous retrospective study highlighted the prophylactic effectiveness of oral calcium drinks before apheresis, supplemented with intravenous calcium gluconate. Conseq...
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Elsevier
2024-12-01
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| Series: | Hematology, Transfusion and Cell Therapy |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2531137924003250 |
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| author | Masaya Abe Keiko Fujii Nobuharu Fujii Toshiharu Mitsuhashi Takuya Fukumi Yuichi Sumii Maiko Kimura Tomohiro Urata Takumi Kondo Fumio Otsuka Yoshinobu Maeda |
| author_facet | Masaya Abe Keiko Fujii Nobuharu Fujii Toshiharu Mitsuhashi Takuya Fukumi Yuichi Sumii Maiko Kimura Tomohiro Urata Takumi Kondo Fumio Otsuka Yoshinobu Maeda |
| author_sort | Masaya Abe |
| collection | DOAJ |
| description | Background: Citrate-related hypocalcemia is the most common adverse event linked with peripheral blood progenitor cell apheresis. A previous retrospective study highlighted the prophylactic effectiveness of oral calcium drinks before apheresis, supplemented with intravenous calcium gluconate. Consequently, this study is a randomized controlled trial comparing oral calcium with placebo drinks Study Design and Methods: Healthy donors were randomized to receive either oral calcium (Cohort A) or placebo (Cohort B) drinks. If symptoms emerged, all donors were given calcium drinks to counteract hypocalcemia. The primary endpoint centered on the incidence of Grade 1 or higher citrate-related symptoms. Analyses were performed using the crude model and doubly robust estimation. Results: Forty-two healthy donors participated from January 2021 to July 2022. Case distribution (Cohort A: Cohort B) stood at 3:7 (Grade 1), 2:2 (Grade 2), and 1:0 (Grade 3); no Grade 4 cases were identified. There was no statistical significance in the incidence of Grade 1 or higher and Grade 3 citrate-related symptoms. Discussion: The cumulative incidence of citrate-related side effects was less pronounced than in the previous research. This could stem from absence of blinding, and the decision to administer calcium drinks to the untreated group upon symptom detection. Although preemptive oral calcium intake before peripheral blood progenitor cell apheresis is not wholly effective, providing calcium-rich beverages to symptomatic donors may stave off symptom intensification. |
| format | Article |
| id | doaj-art-fe08bca3ec9f421db7f719882c471732 |
| institution | OA Journals |
| issn | 2531-1379 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Hematology, Transfusion and Cell Therapy |
| spelling | doaj-art-fe08bca3ec9f421db7f719882c4717322025-08-20T02:32:19ZengElsevierHematology, Transfusion and Cell Therapy2531-13792024-12-0146S234S24010.1016/j.htct.2024.06.010Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trialMasaya Abe0Keiko Fujii1Nobuharu Fujii2Toshiharu Mitsuhashi3Takuya Fukumi4Yuichi Sumii5Maiko Kimura6Tomohiro Urata7Takumi Kondo8Fumio Otsuka9Yoshinobu Maeda10Department of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Division of Transfusion, Okayama University Hospital, Okayama, JapanDivision of Clinical Laboratory, Okayama University Hospital, Okayama, Japan; Department of Hematology and Oncology, Okayama University Hospital, Okayama, Japan; Corresponding author at: Division of Clinical Laboratory, Okayama University Hospital, Okayama, Japan, 2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan.Division of Transfusion, Okayama University Hospital, Okayama, Japan; Department of Hematology and Oncology, Okayama University Hospital, Okayama, JapanCenter for Innovative Clinical Medicine, Okayama University Hospital, Okayama, JapanDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Division of Transfusion, Okayama University Hospital, Okayama, JapanDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Division of Transfusion, Okayama University Hospital, Okayama, JapanDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Division of Transfusion, Okayama University Hospital, Okayama, JapanDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Division of Transfusion, Okayama University Hospital, Okayama, JapanDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Division of Transfusion, Okayama University Hospital, Okayama, JapanDivision of Clinical Laboratory, Okayama University Hospital, Okayama, Japan; Department of General Medicine, Dentistry and Pharmaceutical Sciences, Okayama University Graduate School of Medicine, Okayama, JapanDepartment of Hematology, Oncology and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan; Department of Hematology and Oncology, Okayama University Hospital, Okayama, JapanBackground: Citrate-related hypocalcemia is the most common adverse event linked with peripheral blood progenitor cell apheresis. A previous retrospective study highlighted the prophylactic effectiveness of oral calcium drinks before apheresis, supplemented with intravenous calcium gluconate. Consequently, this study is a randomized controlled trial comparing oral calcium with placebo drinks Study Design and Methods: Healthy donors were randomized to receive either oral calcium (Cohort A) or placebo (Cohort B) drinks. If symptoms emerged, all donors were given calcium drinks to counteract hypocalcemia. The primary endpoint centered on the incidence of Grade 1 or higher citrate-related symptoms. Analyses were performed using the crude model and doubly robust estimation. Results: Forty-two healthy donors participated from January 2021 to July 2022. Case distribution (Cohort A: Cohort B) stood at 3:7 (Grade 1), 2:2 (Grade 2), and 1:0 (Grade 3); no Grade 4 cases were identified. There was no statistical significance in the incidence of Grade 1 or higher and Grade 3 citrate-related symptoms. Discussion: The cumulative incidence of citrate-related side effects was less pronounced than in the previous research. This could stem from absence of blinding, and the decision to administer calcium drinks to the untreated group upon symptom detection. Although preemptive oral calcium intake before peripheral blood progenitor cell apheresis is not wholly effective, providing calcium-rich beverages to symptomatic donors may stave off symptom intensification.http://www.sciencedirect.com/science/article/pii/S2531137924003250Allogeneic peripheral blood progenitor cell collectionCitrate-related adverse effectOral calcium drinkIonized calcium |
| spellingShingle | Masaya Abe Keiko Fujii Nobuharu Fujii Toshiharu Mitsuhashi Takuya Fukumi Yuichi Sumii Maiko Kimura Tomohiro Urata Takumi Kondo Fumio Otsuka Yoshinobu Maeda Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial Hematology, Transfusion and Cell Therapy Allogeneic peripheral blood progenitor cell collection Citrate-related adverse effect Oral calcium drink Ionized calcium |
| title | Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial |
| title_full | Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial |
| title_fullStr | Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial |
| title_full_unstemmed | Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial |
| title_short | Oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis: an open-label randomized control trial |
| title_sort | oral calcium supplementation versus placebo in mitigating citrate reactions during apheresis an open label randomized control trial |
| topic | Allogeneic peripheral blood progenitor cell collection Citrate-related adverse effect Oral calcium drink Ionized calcium |
| url | http://www.sciencedirect.com/science/article/pii/S2531137924003250 |
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