Examination of clinical effictiveness about cryoprecipitate produced by a new and quick method

2021 Fiscal Year Final Research Report

• Project/Area Number: 20K22945
• Research Category: Grant-in-Aid for Research Activity Start-up
• Allocation Type: Multi-year Fund
• Review Section: 0905:Surgery of the organs maintaining homeostasis and related fields
• Research Institution: The University of Tokyo
• Principal Investigator: Terada Rui 東京大学, 医学部附属病院, 届出研究員 (30880984)
• Project Period (FY): 2020-09-11 – 2022-03-31
• Keywords: 凝固障害 / クリオプレシピテート / 周産期出血

Outline of Final Research Achievements

We changed the study methods from the　original design, i.e., a randomized control study on the cardiac surgeries to a non-randomized, single-group open-label comparative study on the massive obstetric hemorrhages (compared to the historical control). First, we made the prior arrangements such as a pre-study on the coagulation factor activities on the novel hollow fiber membrane prepared cryoprecipitate, explanation to and participation of the related clinical departments, determination on the operation system of the patients’ registration, obtaining approval of the University of Tokyo, Clinical Research Review Board, participation in the clinical insurance, and registration to jRCT（Japan Registry of Clinical Trials). Next, we started the case registration. Since we could not supply the membrane prepared cryoprecipitate in the night-shift time due to the restriction of the staff operation, the research progress has been delayed but is still ongoing.

Free Research Field

輸血医学

Academic Significance and Societal Importance of the Research Achievements

生命を脅かすような周産期の大量出血は、周産期管理の進歩によって、減少してきているものの、いまだ妊産婦死亡原因の第1位を占めている状況である。今回作製した中空糸膜クリオは、輸血開始までの時間を短縮でき、濃縮分画製剤であるため、凝固障害に陥った患者の凝固能をすばやく改善させることができ、大量出血症例においての治療予後に大きく貢献できる可能性がある。今回の研究を通し、中空糸膜クリオの有効性と安全性が証明されれば、出血症例における輸血戦略が大きくかわり、より有効な治療を患者に提供することが期待される。