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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018984

Enrollment

200

Registered

2015-10-01

Start date

2016-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis-induced disseminated intravascular coagulation

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
Mortality on day 30	—

Secondary

Measure	Time frame
Recovery from DIC on day 3 and day6 ARDS	—

Countries

Japan

Contacts

Public ContactToshihiro Sakurai

National Hospital Organization Kumamoto Medical Center Department of Emergency and Critical Care Medicine

tsakurai@kumamed.jp096-353-6501

Outcome results