Unique ID issued by UMIN | UMIN000018984 |
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Receipt number | R000014770 |
Scientific Title | Clinical evaluation of protein C activity in sepsis-induced disseminated intravascular coagulation |
Date of disclosure of the study information | 2015/10/01 |
Last modified on | 2018/09/13 17:25:42 |
Clinical evaluation of protein C activity in sepsis-induced disseminated intravascular coagulation
PC-DIC study
Clinical evaluation of protein C activity in sepsis-induced disseminated intravascular coagulation
PC-DIC study
Japan |
Sepsis-induced disseminated intravascular coagulation
Emergency medicine | Intensive care medicine |
Others
NO
To investigate protein C activity at the time of DIC diagnosis whether it can be a prognostic factor of sepsis-induced DIC.
Efficacy
Confirmatory
Pragmatic
Not applicable
Mortality on day 30
Recovery from DIC on day 3 and day6
ARDS
Observational
18 | years-old | <= |
Not applicable |
Male and Female
The patients 18years old or more who need hospitalization to treat sepsis-induced DIC. We use the Japanese Association for Acute Medicine (JAAM) DIC diagnostic criteria. DIC is diagnosed when the JAAM DIC score is four points or more. We consider that they recover from DIC when the JAAM DIC score is three points or less.
We exclude the following patients who may have conditions affecting prognosis other than infection, or affecting protein C activity.
1) Patients with hematopoietic malignancy such as leukemia, or solid cancer.
2) Patients having immunodeficiency disorder, such as myelodysplastic syndrome, myeloproliferative disorder, and acquired immunodeficiency syndrome.
3) Patients having severe liver cirrhosis (Child-Pugh B or C).
4) Patients having exogenous disease such as severe injury, severe burn,or heat stroke. Severe injury is defined as conditions having 3 points or more in at least one body part of AIS90 Update98. Severe burn is defined as conditions having 3 points or more in at least one body part of AIS90 Update98. Heat stroke is defined as grade III in Yasuoka classification.
5) Patients having protein C deficiency disease.
6) Patients or legal representative refuse written informed consent.
7) Patients receiving anti-DIC therapy at the time of entry, such as heparin (unfractionated heparin, low molecular weight heparin), heparinoid, antithrombin, recombinant human thrombomodulin, serine protease inhibitor (gabexate mesilate, nafamostat mesilete).
200
1st name | |
Middle name | |
Last name | Toshihiro Sakurai |
National Hospital Organization Kumamoto Medical Center
Department of Emergency and Critical Care Medicine
1-5 Ninomaru, Chuo-ku, Kumamoto, 860-0008 Japan
096-353-6501
tsakurai@kumamed.jp
1st name | |
Middle name | |
Last name | Toshihiro Sakurai |
National Hospital Organization Kumamoto Medical Center
Department of Emergency and Critical Care Medicine
1-5 Ninomaru, Chuo-ku, Kumamoto, 860-0008 Japan
096-353-6501
tsakurai@kumamed.jp
National Hospital Organization Kumamoto Medical Center
none
Self funding
NO
2015 | Year | 10 | Month | 01 | Day |
Unpublished
Completed
2015 | Year | 09 | Month | 09 | Day |
2016 | Year | 01 | Month | 01 | Day |
I. Study design
A multicenter prospective cohort study.
II. Method of recruiment of target patients
The patients who meet including criteria among hospitalized from October 1, 2015 to December 31, 2017.
We will register patients with this study if we can obtain consent from patient or representative.
III. Data collection
1) Baseline data
<Background data>
Age, Sex, BMI, Source of infection (main diagnosis), anticoagulant drug, antiplatelet drug
<Past history>
Maintenance dialysis, severe chronic heart failure, chronic pulmonary disease, chronic renal disease
<Vital sign>
Core temperature, mean arterial pressure, heart rate, respiratory rate, level of consciousness (Glasgow coma scale)
<Laboratory data>
Hematological test
Blood count (WBC, neocyte(%), platelet, hematocrit)
Biochemistry (Serum Na, K, BUN, creatinine, total bilirubin, CRP, PCT, HbA1c (NGSP))
Coagulation (PT(%), fibrinogen, FDP, D-dimer, AT, protein C, alpha2PI, TAT, FM test)
Blood gas analysis (pH, A-aDO2 (FiO2>=0.5), PaO2(FiO2<0.5))
HbA1c can be measured within 5 days from DIC diagnosis day. Underlining points are optional points.
2) Clinical course data
-Anti-DIC therapy (drug name, dose, duration)
-Surgical treatment
-Artificial ventilation
-Blood transfusion
-Emergency blood purification (CHDF, Direct hemoperfusion with polymyxin B immobilized fiber; PMX-DHP)
IV. Endpoints
(1) Primary endpoint:
-Mortality on day 30
(2) Secondary endpoints:
-Recovery from DIC on day 3 and day 6
-ARDS
V. Statistical consideration
Statistical analysis was performed to determine the association between relevant risk factors and mortality with the Pearson chi-square test using categorical variables or with Mann-Whitney U test using continuous variables. A logistic regression analysis was performed with factors found to be significantly associated with mortality based on the above univariate analysis results.
2015 | Year | 09 | Month | 11 | Day |
2018 | Year | 09 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014770
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