PMID- 30296304
OWN - NLM
STAT- MEDLINE
DCOM- 20190408
LR  - 20190408
IS  - 1932-6203 (Electronic)
IS  - 1932-6203 (Linking)
VI  - 13
IP  - 10
DP  - 2018
TI  - Assessment of bleeding in patients with disseminated intravascular coagulation 
      after receiving surgery and recombinant human soluble thrombomodulin: A cohort 
      study using a database.
PG  - e0205146
LID - 10.1371/journal.pone.0205146 [doi]
LID - e0205146
AB  - We aimed to investigate the incidence of bleeding-related adverse events (AEs) 
      among patients with disseminated intravascular coagulation (DIC) receiving 
      recombinant thrombomodulin (rTM) and those receiving other DIC treatments, the 
      incidence by type of surgery, and the incidence when either blood transfusion or 
      a hemostatic procedure was administered to treat DIC. In this cohort study, data 
      were obtained from a large medical database (22 centers in Japan). The primary 
      endpoint was the incidence rate of bleeding-related AEs by type of surgery. The 
      secondary endpoint was the incidence rate of bleeding-related AEs based on 
      whether blood transfusion or a hemostatic procedure was administered after the 
      day of DIC treatment. In total, 4234 propensity score-matched patients were 
      included in the main analysis (2117 patients each in the rTM and non-rTM groups). 
      In the rTM and non-rTM groups, respectively, the incidence of bleeding-related 
      AEs was 18.8% and 24.8% (p <0.001; risk ratio [RR] 0.757, 95% confidence interval 
      [CI] 0.674-0.849), among patients requiring any type of surgery; 15.0% and 19.5% 
      (p = 0.0001; RR 0.769, 95% CI 0.673-0.879) in patients requiring blood 
      transfusion or a hemostatic procedure after the day of DIC treatment; 10.2% and 
      11.6% (p = 0.4470; RR 0.879, 95% CI 0.630-1.226) in patients undergoing hepatic, 
      biliary, or pancreatic surgery; 24.3% and 25.4% (p = 0.6439; RR 0.955, 95% CI 
      0.786-1.160) in patients undergoing gastrointestinal surgeries; and 18.5% and 
      30.1% (p = 0.0001; RR 0.614, 95% CI 0.481-0.782) in patients undergoing cardiac 
      or cardiovascular surgery. Our findings suggest that rTM treatment for Japanese 
      postsurgical patients who develop DIC was associated with significantly fewer 
      bleeding-related AEs compared with those receiving other DIC treatments.
FAU - Yamaguchi, Takuhiro
AU  - Yamaguchi T
AUID- ORCID: 0000-0002-7961-9417
AD  - Division of Biostatistics, Tohoku University Graduate School of Medicine, Sendai, 
      Japan.
FAU - Kitajima, Yukio
AU  - Kitajima Y
AD  - Medical Affairs Division, CAC Croit Corporation, Chuo-ku, Tokyo, Japan.
FAU - Miyauchi, Yasuhiro
AU  - Miyauchi Y
AD  - Medical Affairs Division, CAC Croit Corporation, Chuo-ku, Tokyo, Japan.
FAU - Izawa, Kazutoshi
AU  - Izawa K
AD  - Medical Affairs Division, CAC Croit Corporation, Chuo-ku, Tokyo, Japan.
FAU - Tanaka, Masakazu
AU  - Tanaka M
AD  - Medical Affairs Division, CAC Croit Corporation, Chuo-ku, Tokyo, Japan.
FAU - Hirata, Masatada
AU  - Hirata M
AD  - Medical Affairs Division, CAC Croit Corporation, Chuo-ku, Tokyo, Japan.
FAU - Sadatsuki, Yasunari
AU  - Sadatsuki Y
AD  - Medical Affairs Division, CAC Croit Corporation, Chuo-ku, Tokyo, Japan.
FAU - Ogawa, Yoshihiro
AU  - Ogawa Y
AD  - Medical Affairs Division, CAC Croit Corporation, Chuo-ku, Tokyo, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
DEP - 20181008
PL  - United States
TA  - PLoS One
JT  - PloS one
JID - 101285081
RN  - 0 (Anticoagulants)
RN  - 0 (Recombinant Proteins)
RN  - 0 (THBD protein, human)
RN  - 0 (Thrombomodulin)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Anticoagulants/adverse effects/*therapeutic use
MH  - Blood Transfusion
MH  - Cohort Studies
MH  - Disseminated Intravascular Coagulation/epidemiology/*therapy
MH  - Female
MH  - Humans
MH  - Incidence
MH  - Male
MH  - Middle Aged
MH  - *Postoperative Hemorrhage/epidemiology/therapy
MH  - Recombinant Proteins/adverse effects/therapeutic use
MH  - Risk Factors
MH  - Thrombomodulin/*therapeutic use
MH  - Treatment Outcome
MH  - Young Adult
PMC - PMC6175500
COIS- This study was funded by Asahi Kasei Pharma Corporation. Takuhiro Yamaguchi has 
      received honoraria (lecture fees) from Asahi Kasei Pharma Corporation. Asahi 
      Kasei Pharma Corporation purchased data from MDV and provided those data to the 
      study researchers. Yukio Kitajima, Yasuhiro Miyauchi, Kazutoshi Izawa, Masakazu 
      Tanaka, Masatada Hirata, Yasunari Sadatsuki, and Yoshihiro Ogawa are employed by 
      CAC Croit Corporation. CAC Croit Corporation, as a study secretariat, has 
      received funding from Asahi Kasei Pharma Corporation. There are no patents, 
      products in development, or marketed products to declare. This does not alter our 
      adherence to all PLOS ONE policies on sharing data and materials, as detailed 
      online in the Guide for Authors.
EDAT- 2018/10/09 06:00
MHDA- 2019/04/09 06:00
PMCR- 2018/10/08
CRDT- 2018/10/09 06:00
PHST- 2018/03/22 00:00 [received]
PHST- 2018/09/20 00:00 [accepted]
PHST- 2018/10/09 06:00 [entrez]
PHST- 2018/10/09 06:00 [pubmed]
PHST- 2019/04/09 06:00 [medline]
PHST- 2018/10/08 00:00 [pmc-release]
AID - PONE-D-18-08816 [pii]
AID - 10.1371/journal.pone.0205146 [doi]
PST - epublish
SO  - PLoS One. 2018 Oct 8;13(10):e0205146. doi: 10.1371/journal.pone.0205146. 
      eCollection 2018.