UMIN-CTR Clinical Trial

Public title

Clinical evaluation of protein C activity in sepsis-induced disseminated intravascular coagulation

Acronym

PC-DIC study

Scientific Title

Clinical evaluation of protein C activity in sepsis-induced disseminated intravascular coagulation

Scientific Title:Acronym

PC-DIC study

Region

Japan

Condition

Sepsis-induced disseminated intravascular coagulation

Classification by specialty

Emergency medicine

Intensive care medicine

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Mortality on day 30

Key secondary outcomes

Recovery from DIC on day 3 and day6
ARDS

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Toshihiro Sakurai

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Department of Emergency and Critical Care Medicine

Zip code

Address

1-5 Ninomaru, Chuo-ku, Kumamoto, 860-0008 Japan

TEL

096-353-6501

Email

tsakurai@kumamed.jp

Name of contact person

1st name
Middle name
Last name	Toshihiro Sakurai

Organization

National Hospital Organization Kumamoto Medical Center

Division name

Department of Emergency and Critical Care Medicine

Zip code

Address

1-5 Ninomaru, Chuo-ku, Kumamoto, 860-0008 Japan

TEL

096-353-6501

Homepage URL

Email

tsakurai@kumamed.jp

Institute

National Hospital Organization Kumamoto Medical Center

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

10

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2015

Year

09

Month

09

Day

Date of IRB

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

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.

Registered date

2015

Year

09

Month

11

Day

Last modified on

2018

Year

09

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014770