Efficacy and Safety of Unfractionated Heparin on Severe Sepsis With Suspected Disseminated Intravascular Coagulation

November 15, 2023 updated by: Xiaochun Ma,MD, China Medical University, China

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • People's Hospital of Peking University
        • Contact:
          • youzhong an, doctor
        • Principal Investigator:
          • jie lv, doctor
      • Beijing, China
        • Recruiting
        • Beijing Friendship Hospital , Capital Medical University
        • Contact:
          • meili duan
        • Principal Investigator:
          • yu qiu, doctor
      • Beijing, China
        • Recruiting
        • Changgeng Hospital of Tsinghua University
        • Contact:
          • yuan xu
      • Jilin, China
        • Recruiting
        • First Affiliated Hospital of Jilin Medical University
        • Contact:
          • dong zhang
        • Principal Investigator:
          • lina gu
      • Qinhuangdao, China
        • Recruiting
        • Qinhuangdao First Hospital
        • Contact:
          • xiujuan liu
      • Shenyang, China
        • Recruiting
        • Liaoning Provincial People's Hospital
        • Contact:
          • xinghuo feng
        • Principal Investigator:
          • chengshu dong, master
    • Heilongjiang
      • Haerbin, Heilongjiang, China
        • Recruiting
        • The fist Affiliated Hospital Harbin Medical University
        • Contact:
          • wei yang, master
        • Principal Investigator:
          • mingyan zhao, doctor
    • Hunan
      • Changsha, Hunan, China
        • Recruiting
        • Xiangya Third Hospital of Central South University
        • Contact:
          • min gao
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recruiting
        • Zhongda hospital
        • Contact:
          • chun pan, MD
        • Principal Investigator:
          • chun pan, doctor
        • Contact:
          • Haibo Qiu, MD
    • Liaoning
      • Dalian, Liaoning, China
        • Recruiting
        • First Affiliated Hospital of Dalian Medical University
        • Contact:
          • xianyao wan
        • Principal Investigator:
          • chen chen, master
      • Dalian, Liaoning, China
        • Recruiting
        • Second Affiliated Hospital of Dalian Medical University
        • Contact:
          • jian yu
        • Principal Investigator:
          • dandan zhu
      • Shenyang, Liaoning, China
        • Recruiting
        • second Affiliated Hospital of china Medical University
        • Contact:
          • bin zang, doctor
        • Principal Investigator:
          • di chang, master
      • Shenyang, Liaoning, China
        • Recruiting
        • Shenyang Fourth People's Hospital
        • Contact:
          • Wei Feng
        • Principal Investigator:
          • yinan guo, master
    • Shandong
      • Qingdao, Shandong, China
        • Recruiting
        • Qilu Hospital of Shandong University(Qingdao)
        • Contact:
          • dawei wu
        • Principal Investigator:
          • chanyuan bu, master
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • West China Hospital of Sichuan University
        • Contact:
          • yan kang
        • Principal Investigator:
          • qin sun, doctor
    • Yunnan
      • Kunming, Yunnan, China
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • Li Wang
        • Contact:
          • chuanyun qian
      • Kunming, Yunnan, China
        • Recruiting
        • the Second Affiliated Hospital of Kunming University
        • Contact:
          • qingqing huang, doctor
        • Contact:
          • yuanyuan wang, doctor
        • Principal Investigator:
          • yuangyuan wang, doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Saline
Drug: 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.
Other Names:
  • Normal saline
Experimental: Heparin
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: 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.
Other Names:
  • Normal saline
Drug: 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.
Other Names:
  • Unfractionated heparin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
ICU mortality
Time Frame: during ICU stay (up to day 28)
The mortality during ICU stay
during ICU stay (up to day 28)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
28-day all-cause mortality
Time Frame: after 28 days of enrollment of all the cases
The all-cause mortality at day 28 after enrollment
after 28 days of enrollment of all the cases
the incidence of major bleeding
Time Frame: during ICU stay (up to day 28)
"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
during ICU stay (up to day 28)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in SOFA scores
Time Frame: during the intervention period (up to day 7 after enrollment)
The difference of SOFA scores between day 7 and day 1 upon enrollment
during the intervention period (up to day 7 after enrollment)
Change in JAAM and ISTH scores
Time Frame: during the intervention period (up to day 7 upon enrollment)
The difference of JAAM and ISTH scores between day7 and day1 upon enrollment
during the intervention period (up to day 7 upon enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China Medical University, China

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Nanchang University
Peking University People's Hospital
Beijing Friendship Hospital
West China Hospital
Qilu Hospital of Shandong University
Shengjing Hospital
The Affiliated Hospital of Qingdao University
The People's Hospital of Liaoning Province
The First Hospital of Jilin University
Zhongda Hospital
General Hospital of Ningxia Medical University
The First Affiliated Hospital of Dalian Medical University
First Affiliated Hospital of Harbin Medical University
The First Hospital of Qinhuangdao
The Second Affiliated Hospital of Dalian Medical University
The Second Affiliated Hospital of Kunming Medical University
Beijing Tsinghua Changgeng Hospital
Fourth People's Hospital of Shenyang
First Affiliated Hospital of Kunming Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 12, 2018

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 12, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2016

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 17, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LNCCC-B01-2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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