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Clinical trial

Phase 3 Study of the Efficacy and Safety of Unfractionated Heparin in Patients With Severe Sepsis/Septic Shock With Suspected DIC

ID
Name
LNCCC-B01-2014
Description
The primary objective of this study is to estimate the efficacy of unfractionated heparin(UFH) on ICU mortality in severe sepsis with suspected DIC.The Second objective is to estimate the effect of UFH on 28-day mortality,and the change of the Japanese Association for Acute Medicine(JAAM) score and SOFA score. The third one is to evaluate the safety of UFH in severe sepsis patients with suspected DIC.
Trial arms
Trial start
2018-04-12
Estimated PCD
2024-12-01
Trial end
2025-06-01
Status
Recruiting
Phase
Early phase I
Treatment
Heparin Sodium
A bottle solution of Heparin Sodium(2ml:12500IU) is added to 50ml saline and administered i.v. continuously for 24 hours, which last 7 days or until the death or discharge. The same amount of 0.9% saline as the heparin group will be administered in the placebo group.
Arms:
Heparin
Other names:
Unfractionated heparin
Saline
For all the severe sepsis or septic shock patients, normal saline will be administered for fluid resuscitation according to the Guideline of Survival Sepsis Campaign.
Arms:
Heparin, Saline
Other names:
Normal saline
Size
600
Primary endpoint
ICU mortality
during ICU stay (up to day 28)
Eligibility criteria
Inclusion Criteria: * Clinical diagnosis of severe sepsis or/and septic shock * suspected DIC:the score of Platelets plus International Normalized Ratio in the JAAM criteria is equal or more than 3 scores Exclusion Criteria: * consent declined * pregnant or breastfeeding * the length during ICU is less than 24 hours * with other types of shock * have bleeding or high risk for bleeding * have an indication for therapeutic anticoagulation * have a known or suspected adverse reaction to UFH including HIT * are currently enrolled in another trial * known or suspected cirrhosis or other severe hepatic diseases * terminal illness with a life expectancy of less than 28 days
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}
Updated at
2023-11-18

1 organization

1 product

1 drug

2 indications

Organization
China Medical University
Product
Heparin Sodium
Indication
Sepsis
Indication
Disseminated Intravascular Coagulation
Drug
Varlilumab