A Phase 3 interventional study of Heparin Sodium and Saline in Sepsis and Disseminated Intravascular Coagulation, sponsored by China Medical University, China. Status unknown at 17 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-18.
Sponsored by China Medical University, China · Phase 3, Interventional, and Treatment
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.
During the study, the whole process of data validation and registry procedures will be implemented by the Principal Investigator of the study, and monitored by the Ethics Committee of the First Affiliated Hospital of China Medical University.There are 2 research supervisors(2 ICU doctors) to assess the accuracy, completeness and representativeness of registry data, and to report the study process and research results to Principal Investigator.Investigators have also edited a data dictionary including each variable used by the registry and normal ranges of all detection indexes. The standard operating procedures have been formulated to address the registry and data analysis. The feasibility and significance have been assessed carefully and funded by the Health and Family Planning Commission of Liaoning Province(No.LNCC-B01-2014).The sample size is 600 participants through statistic calculation. The plan for missing data and statistical analysis will be implemented by specialized statisticians of China Medical University.
1,946 studies on the registry are indexed under Sepsis; 471 are open to participants now.
This study's planned enrollment of 600 is above the median of 105 across 918 interventional studies indexed under Sepsis.
Browse Sepsis studies →China Medical University, China is the lead sponsor of 94 studies on the registry; 34 are open to participants now.
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Exclusion Criteria:
Drug: Saline
If severe sepsis with suspected DIC is diagnosed, the Heparin sodium(2ml:12500 units) will be administered intravenously continuously for 24 hours. The course of treatment will last 7 days or until the death or discharge.
Drug: Heparin Sodium · Drug: Saline
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.
Also known as: Unfractionated heparin
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.
Also known as: Normal saline
ICU mortality
The mortality during ICU stay
Time frame: during ICU stay (up to day 28)
28-day all-cause mortality
The all-cause mortality at day 28 after enrollment
Time frame: after 28 days of enrollment of all the cases
the incidence of major bleeding
"Major bleeding" is defined as intracranial bleeding, life-threatening bleeding, or need red blood cell suspension more than 3 units every 24 hours,and last for 2 days
Time frame: during ICU stay (up to day 28)
Change in SOFA scores
The difference of SOFA scores between day 7 and day 1 upon enrollment
Time frame: during the intervention period (up to day 7 after enrollment)
Change in JAAM and ISTH scores
The difference of JAAM and ISTH scores between day7 and day1 upon enrollment
Time frame: during the intervention period (up to day 7 upon enrollment)
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Heparin
China Medical University, China