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

Summary

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.

Conditions

• Sepsis
• Disseminated Intravascular Coagulation

Interventions

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.

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.

Sponsors & Collaborators

• West China Hospital

  collaborator OTHER

• Zhongda Hospital

  collaborator OTHER

• The First Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• Shengjing Hospital

  collaborator OTHER

• The First Hospital of Jilin University

  collaborator OTHER

• Qilu Hospital of Shandong University

  collaborator OTHER

• The Second Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• The First Hospital of Qinhuangdao

  collaborator OTHER_GOV

• The Second Affiliated Hospital of Dalian Medical University

  collaborator OTHER

• First Affiliated Hospital of Harbin Medical University

  collaborator OTHER

• Peking University People's Hospital

  collaborator OTHER

• The People's Hospital of Liaoning Province

  collaborator OTHER

• Fourth People's Hospital of Shenyang

  collaborator OTHER

• Beijing Tsinghua Changgeng Hospital

  collaborator OTHER

• First Affiliated Hospital of Kunming Medical University

  collaborator OTHER

• The Affiliated Hospital of Qingdao University

  collaborator OTHER

• Beijing Friendship Hospital

  collaborator OTHER

• General Hospital of Ningxia Medical University

  collaborator OTHER

• The First Affiliated Hospital of Nanchang University

  collaborator OTHER

• China Medical University, China

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-04-12

Primary Completion

2024-12-31

Completion

2025-06-30

Countries

• China

Study Locations