Prospective randomized trial fibrinogen concentrates for hemorrhagic shock patients.

• Project/Area Number: 15K10969
• Research Category: Grant-in-Aid for Scientific Research (C)
• Allocation Type: Multi-year Fund
• Section: 一般
• Research Field: Emergency medicine
• Research Institution: Tokyo Medical and Dental University
• Principal Investigator: Murata Kiyoshi 東京医科歯科大学, 医学部附属病院, 非常勤講師 (60527175)
• Co-Investigator(Kenkyū-buntansha): 大友 康裕 東京医科歯科大学, 大学院医歯学総合研究科, 教授 (40176946)
• Project Period (FY): 2015-04-01 – 2021-03-31
• Project Status: Completed (Fiscal Year 2020)
• Budget Amount: ¥4,810,000 (Direct Cost: ¥3,700,000、Indirect Cost: ¥1,110,000); Fiscal Year 2019: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2018: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2017: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2016: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000); Fiscal Year 2015: ¥1,170,000 (Direct Cost: ¥900,000、Indirect Cost: ¥270,000)
• Keywords: 外傷外科 / 出血性ショック / 大量輸血 / フィブリノゲン / 外傷性血液凝固障害

Outline of Final Research Achievements

We cannot use fibrinogen concentrates to massive bleeding patients in Japan. The aim of this study is to clear the effectiveness of fibrinogen concentrates for hemorrhagic shock patients. Firstly, We performed big data analysis using DPC data. Secondly, we conduct randomized trial. This two studies suggest no benefit of fibrinogen concentrates for hemorrhagic shock patients to improve mortality and to decrease amount of transfusion.

Academic Significance and Societal Importance of the Research Achievements

残念ながら本研究では出血性ショック患者に対するフィブリノゲン濃縮製剤の効果を証明できなかった。しかしながら保険適応外でも利用されている現状はDPCデータでも確認でき、その効果が限定的である可能性が示された。さらなる研究が必要ではあるが、フィブリノゲン濃縮製剤の役割が今後明確になっていく中で、貴重なフィブリノゲン濃縮製剤の適正利用が進むものと考えられ、今後の医療現場での大量出血患者に対する適切な治療選択に向けて一定の情報として発信できる結果が得られた。

Research Products

• [Journal Article] Age related differences in the impact of coagulopathy in patients with isolated traumatic brain injury: An observational cohort study. (2020)
  • Author(s): Takayama W, Murata K, et al.
  • Journal Title: J Trauma Acute Care Surgery Volume: 89(3) Issue: 3 Pages: 523-528
  • DOI: 10.1097/ta.0000000000002796
  • Peer Reviewed
• [Journal Article] Evaluation of manual chest compressions according to the updated cardiopulmonary resuscitation guidelines and the impact of feedback devices in an educational resuscitation course. (2020)
  • Author(s): Urushibara N, Murata K, et al.
  • Journal Title: BMC Emerg Med. Volume: 20(1) Issue: 1 Pages: 49-49
  • DOI: 10.1186/s12873-020-00345-8
  • Peer Reviewed / Open Access
• [Journal Article] Planned Versus On-Demand Re-laparotomy Strategy in initial Surgery for Non-occlusive Mesenteric Ischemia. (2020)
  • Author(s): Endo A, Murata K, et al.
  • Journal Title: J Gastrointestinal Surg. Volume: sep 15 Issue: 7 Pages: 1-10
  • DOI: 10.1007/s11605-020-04792-3
  • Peer Reviewed / Open Access
• [Journal Article] Volume-outcome relationship on survival and cost benefits in severe burn injury: a retrospective analysis of a Japanese nationwide administrative database (2019)
  • Author(s): Endo A, Shiraishi A, Fushimi K, Murata K, Otomo Y
  • Journal Title: Journal of intensive care Volume: 7 Issue: 1 Pages: 7-7
  • DOI: 10.1186/s40560-019-0363-7
  • Peer Reviewed / Open Access / Int'l Joint Research
• [Journal Article] Differences in durations, adverse events, and outcomes of in-hospital cardiopulmonary resuscitation between day-time and night-time: An observational cohort study. (2019)
  • Author(s): Takayama W, Endo A, Koguchi H, Murata K, Otomo Y.
  • Journal Title: Resuscitation Volume: April;137 Pages: 14-20
  • DOI: 10.1016/j.resuscitation.2019.01.023
  • Peer Reviewed
• [Journal Article] Decision-making criteria for damage control surgery in Japan. (2019)
  • Author(s): Urushibata N, Murata K, Otomo Y.
  • Journal Title: Sci Rep. Volume: Oct 17;9(1) Issue: 1 Pages: 14895-14895
  • DOI: 10.1038/s41598-019-51436-x
  • Peer Reviewed
• [Journal Article] Impact of continuous regional arterial infusion in the treatment of acute necrotizing pancreatitis: analysis of a national administrative database (2018)
  • Author(s): Endo Akira、Shiraishi Atsushi、Fushimi Kiyohide、Murata Kiyoshi、Otomo Yasuhiro
  • Journal Title: Journal of Gastroenterology Volume: Epub ahead of print Issue: 9 Pages: 1-1
  • DOI: 10.1007/s00535-018-1452-4
  • Peer Reviewed
• [Journal Article] The impact of blood type O on mortality of severe trauma patients: a retrospective observational study (2018)
  • Author(s): Takayama Wataru、Endo Akira、Koguchi Hazuki、Sugimoto Momoko、Murata Kiyoshi、Otomo Yasuhiro
  • Journal Title: Critical Care Volume: 22 Issue: 1 Pages: 1-1
  • DOI: 10.1186/s13054-018-2022-0
• [Journal Article] 大量輸血と外傷治療 (2018)
  • Author(s): 村田希吉
  • Journal Title: 日本医師会雑誌 Volume: 146 Pages: 2230-2230
• [Journal Article] Hyperfibrinolysis in severe isolated traumatic brain injury may occur without tissue hypoperfusion: a retrospective observational multicentre study (2017)
  • Author(s): Hayakawa Mineji、Kushimoto Shigeki、Ogura Hiroshi、Matsuoka Tetsuya、Morimura Naoto、Ishikura Hiroyasu、Kaneko Naoyuki、Nakamura Yoshihiko、Shiraishi Atsushi、Murata Kiyoshi
  • Journal Title: Critical Care Volume: 21 Issue: 1 Pages: 1-1
  • DOI: 10.1186/s13054-017-1811-1
  • NAID: 120006360078
  • Peer Reviewed / Open Access
• [Journal Article] Open-chest versus closed-chest cardiopulmonary resuscitation in blunt trauma: analysis of a nationwide trauma registry (2017)
  • Author(s): Endo Akira、Shiraishi Atsushi、Otomo Yasuhiro、Tomita Makoto、Matsui Hiroki、Murata Kiyoshi
  • Journal Title: Critical Care Volume: 21 Issue: 1 Pages: 1-1
  • DOI: 10.1186/s13054-017-1759-1
  • Peer Reviewed / Open Access
• [Journal Article] Increased Severe Trauma Patient Volume is Associated With Survival Benefit and Reduced Total Health Care Costs (2017)
  • Author(s): Endo Akira、Shiraishi Atsushi、Fushimi Kiyohide、Murata Kiyoshi、Otomo Yasuhiro
  • Journal Title: Annals of Surgery Volume: Epub ahead of print Issue: 6 Pages: 1-1
  • DOI: 10.1097/sla.0000000000002324
  • Peer Reviewed
• [Journal Article] Effectiveness of early administration of tranexamic acid in patients with severe trauma. (2017)
  • Author(s): Shiraishi A, Kushimoto S, Otomo Y, Matsui H, Hagiwara A, Murata K; Japanese Observational Study for Coagulation and Thrombolysis in Early Trauma (J-OCTET) investigators.
  • Journal Title: British Journal of Surgery Volume: 104 Issue: 6 Pages: 710-717
  • DOI: 10.1002/bjs.10497
  • Peer Reviewed / Acknowledgement Compliant
• [Journal Article] Fibrinogen level on admission is a predictor for massive transfusion in patients with severe blunt trauma: Analyses of a retrospective multicentre observational study. (2017)
  • Author(s): Nakamura Y, Murata K, et al.
  • Journal Title: Injury Volume: 48 Issue: 3 Pages: 674-679
  • DOI: 10.1016/j.injury.2017.01.031
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] 病院前輸液は外傷性血液凝固障害のリスク因子である (2016)
  • Author(s): 村田希吉
  • Journal Title: 日本外傷学会雑誌 Volume: 30 Pages: 341-347
  • NAID: 130005166408
  • Peer Reviewed / Open Access
• [Journal Article] Damage Control Surgeryの新しい適応基準 (2016)
  • Author(s): 村田希吉
  • Journal Title: 日本腹部救急医学会雑誌 Volume: 36 Pages: 1023-1026
  • NAID: 130005290469
  • Peer Reviewed / Open Access
• [Journal Article] Development of Novel Criteria of the "Lethal Triad" as an Indicator of Decision Making in Current Trauma Care: A Retrospective Multicenter Observational Study in Japan. (2016)
  • Author(s): Endo A, Shiraishi A, Otomo Y, Kushimoto S, Saitoh D, Hayakawa M, Ogura H, Murata K, Hagiwara A, Sasaki J, Matsuoka T, Uejima T, Morimura N, Ishikura H, Takeda M, Kaneko N, Kato H, Kudo D, Kanemura T, Shibusawa T, Hagiwara Y, Furugori S, Nakamura Y, Maekawa K, Mayama G, Yaguchi A, Kim S, Takasu O, Nishiyama K.
  • Journal Title: Critical Care Medicine Volume: 4 Issue: 9 Pages: 797-803
  • DOI: 10.1097/ccm.0000000000001731
  • Peer Reviewed / Int'l Joint Research
• [Journal Article] HIGH D-DIMER LEVELS PREDICT A POOR OUTCOME IN PATIENTS WITH SEVERE TRAUMA, EVEN WITH HIGH FIBRINOGEN LEVELS ON ARRIVAL: A MULTICENTER RETROSPECTIVE STUDY. (2016)
  • Author(s): Hayakawa M, Maekawa K, Kushimoto S, Kato H, Sasaki J, Ogura H, Matauoka T, Uejima T, Morimura N, Ishikura H, Hagiwara A, Takeda M, Kaneko N, Saitoh D, Kudo D, Kanemura T, Shibusawa T, Furugori S, Nakamura Y, Shiraishi A, Murata K, Mayama G, Yaguchi A, Kim S, Takasu O, Nishiyama K.
  • Journal Title: SHOCK Volume: 45 Issue: 3 Pages: 308-314
  • DOI: 10.1097/shk.0000000000000542
  • NAID: 120005981349
  • Peer Reviewed / Int'l Joint Research
• [Presentation] Fibrinogen concentrate doesn't decrease total amount of transfusion in severe trauma patients. (2019)
  • Author(s): Murata K
  • Organizer: European Congress of Trauma and Emergency Surgery
  • Int'l Joint Research
• [Presentation] Damage Control Surgery：手術時間と予後の関係 (2019)
  • Author(s): 村田希吉
  • Organizer: 第33回日本外傷学会
• [Presentation] フィブリノゲン濃縮製剤は重症外傷患者の輸血量を増やす (2019)
  • Author(s): 村田希吉
  • Organizer: 第33回日本外傷学会
• [Presentation] Challenges in Japanese Society for Acute Care Surgery for next 10 years. (2019)
  • Author(s): 村田希吉
  • Organizer: 第11回日本Acute Care Surgery学会
  • Int'l Joint Research
• [Presentation] Pre-hospital Fluid Resuscitation is a risk factor of Trauma Associated Coagulopathy in Patients With Severe Trauma. (2017)
  • Author(s): Murata K, Otomo Y.
  • Organizer: 18th European Congress of Trauma and Emergency Surgery
  • Int'l Joint Research
• [Presentation] Damage Control導入基準は受傷機転に依存する (2017)
  • Author(s): 村田希吉
  • Organizer: 第117会日本外科学会学術集会
• [Presentation] 新しい外傷死の三徴 (2016)
  • Author(s): 村田希吉
  • Organizer: 第44回日本救急医学会総会
  • Place of Presentation: 新高輪プリンスホテル（東京）
  • Year and Date: 2016-11-17
• [Presentation] Acute Care Surgeryにおける意識レベルの重要性 (2016)
  • Author(s): 村田希吉
  • Organizer: 第71回日本消化器外科学会総会
  • Place of Presentation: アスティ徳島（徳島）
  • Year and Date: 2016-07-14
• [Presentation] 病院前輸液は外傷性血液凝固障害のリスク因子である (2016)
  • Author(s): 村田希吉
  • Organizer: 第20回日本外傷学会学術集会
  • Place of Presentation: ソラシティカンファレンスセンター（東京）
  • Year and Date: 2016-05-30
• [Presentation] Quality Management of Acute Care Surgery Training Program based on PDCA cycle (2016)
  • Author(s): Murata K
  • Organizer: 17th European Congress of Trauma and Emergency Surgery
  • Place of Presentation: Vienna（Austria）
  • Year and Date: 2016-04-24
  • Int'l Joint Research
• [Presentation] 緊急止血術を要する外傷患者の術前CTは必要か？No (2016)
  • Author(s): 村田希吉
  • Organizer: 第116回日本外科学会定期学術集会
  • Place of Presentation: 大阪国際会議場（大阪）
  • Year and Date: 2016-04-16
• [Presentation] PDCAサイクルに基づくAcute care Surgery教育の質改善 (2016)
  • Author(s): 村田希吉
  • Organizer: 第52回日本腹部救急医学会総会
  • Place of Presentation: 東京
  • Year and Date: 2016-03-03
• [Presentation] 重症外傷において病院前輸液が血液凝固機能に及ぼす影響 (2015)
  • Author(s): 村田希吉
  • Organizer: 第29回日本外傷学会学術集会
  • Place of Presentation: 札幌
  • Year and Date: 2015-06-11
• [Presentation] How to decide damage control surgery in trauma care? (2015)
  • Author(s): Murata K
  • Organizer: 16th European Congress of Trauma and Emergency Surgery
  • Place of Presentation: Amsterdam
  • Year and Date: 2015-05-10
  • Int'l Joint Research
• [Book] 今日の治療指針 2019年版［デスク判］ (2019)
  • Author(s): 福井 次矢
  • Total Pages: 2069
  • Publisher: 医学書院
  • ISBN: 9784260036504
• [Book] Lisaコレクション 症例で学ぶ周術期の凝固線溶の管理 (2016)
  • Author(s): 村田希吉
  • Total Pages: 142
  • Publisher: メディカル・サイエンス・インターナショナル
• [Book] 症例で学ぶ周術期の凝固線溶管理 肝損傷 Lisa Collection (2015)
  • Author(s): 村田希吉
  • Total Pages: 10
  • Publisher: MEDSi