UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation of protein C activity in sepsis-induced disseminated intravascular coagulation
Title of the study (Brief title)	PC-DIC study
Region	Japan

Condition
Condition	Sepsis-induced disseminated intravascular coagulation
Classification by specialty	Emergency medicine Intensive care medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate protein C activity at the time of DIC diagnosis whether it can be a prognostic factor of sepsis-induced DIC.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Mortality on day 30
Key secondary outcomes	Recovery from DIC on day 3 and day6 ARDS

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	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.
Key exclusion criteria	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).
Target sample size	200

Research contact person
Name of lead principal investigator	Toshihiro Sakurai
Organization	National Hospital Organization Kumamoto Medical Center
Division name	Department of Emergency and Critical Care Medicine
Address	1-5 Ninomaru, Chuo-ku, Kumamoto, 860-0008 Japan
TEL	096-353-6501
Email	tsakurai@kumamed.jp

Public contact
Name of contact person	Toshihiro Sakurai
Organization	National Hospital Organization Kumamoto Medical Center
Division name	Department of Emergency and Critical Care Medicine
Address	1-5 Ninomaru, Chuo-ku, Kumamoto, 860-0008 Japan
TEL	096-353-6501
Homepage URL
Email	tsakurai@kumamed.jp

Sponsor
Institute	National Hospital Organization Kumamoto Medical Center
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 09 Day
Anticipated trial start date	2016 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	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.

Management information
Registered date	2015 Year 09 Month 11 Day
Last modified on	2018 Year 09 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014770