China Extracorporeal Life Support Registry

Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective cardiac and respiratory support to patients with lungs and/or heart failure. There was a growth in ECLS cases, centers, and center scale in China during the past decade.

This multi-center registry was conducted by Chinese Society of Extracorporeal Life Support. The objectives were to investigate China statistics of ECLS and to evaluate the short-term and long-term outcomes of patients with ECLS.

Study Overview

• Status: Recruiting
• Conditions: Heart Failure; Cardiac Arrest; Acute Respiratory Distress Syndrome; Cardiogenic Shock; Acute Respiratory Failure
• Intervention / Treatment: Device: ECMO

Detailed Description

Extracorporeal life support (ECLS), also known as extracorporeal membrane oxygenation (ECMO), is an extracorporeal technique of providing effective cardiac and respiratory support to patients with lungs and/or heart failure. There was a growth in ECLS cases, centers, and center scale in China during the past decade.

The objectives were to investigate China statistics of ECLS and to evaluate the short-term and long-term outcomes of patients with ECLS.

This multi-center registry was conducted by Chinese Society of Extracorporeal Life Support. Data were submitted by the following member institutions:

AFFILIATED HOSPITAL OF GUANGDONG MEDICAL UNIVERSITY, AFFILIATED HOSPITAL OF JINING MEDICAL UNIVERSITY, AFFILIATED HOSPITAL OF NANTONE UNIVERSITY, AFFILIATED HOSPITAL OF ZUNYI MEDICAL UNIVERSITY, ANHUI PROVINCIAL HOSPITAL, BEIJING ANZHEN HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING CHILDREN'S HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING FRIENDSHIP HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BEIJING CHAO-YANG HOSPITAL, CAPITAL MEDICAL UNIVERSITY, BINZHOU MEDICAL UNIVERSITY HOSPITAL, CHANGHAI HOSPITAL, CHILDREN'S HOSPITAL OF SHANGHAI JIAOTONG UNIVERSITY, CHINESE PLA GENERAL HOSPITAL, DALIAN CENTRAL HOSPITAL, DONGGUAN PEOPLE'S HOSPITAL, FIRST AFFILIATED HOSPITAL OF KUNMING MEDICAL UNIVERSITY, FUJIAN PROVINCIAL HOSPITAL, FUZHOU PULMONARY HOSPITAL OF FUJIAN, GENERAL HOSPITAL OF NINGXIA MEDICAL UNIVERSITY, GUANGDONG PROVINCIAL PEOPLES HOSPITAL, HAINAN GENERAL HOSPITAL, HENAN PROVINCIAL CHEST HOSPITAL, HENAN PROVINCIAL PEOPLES HOSPITAL, NINGBO FIRST HOSPITAL (NINGBO HOSPITAL OF ZHEJIANG UNIVERSITY, PEKING UNION MEDICAL COLLEGE HOSPITAL, PEKING UNIVERSITY PEOPLE'S HOSPITAL, PEKING UNIVERSITY THIRD HOSPITAL, SHANXI PROVINCIAL PEOPLE'S HOSPITAL, SHENGJING HOSPITAL OF CHINAMESICAL UNIVERSITY, SHUNDE HOSPITAL OF SOUTHERN MEDICAL UNIVERSITY, SUZHOU MUNICIPAL HOSPITAL, TAIZHOU HOSPITAL OF ZHEJIANG PROVINCE, THE 2ND AFFILIATED HOSPITAL OF HARBIN MEDICAL UNIVERSITY, THE AFFILIATED HOSPITAL OF HANGZHOU NORMAL UNIVERSITY, THE AFFILIATED HOSPITAL OF QINGDAO UNIVERSITY, THE AFFILIATED HOSPITAL OF XUZHOU MEDICAL UNIVERSITY, THE CHILDREN'S HOSPITAL ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE, THE FIRST AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY, THE FIRST AFFILIATED HOSPITAL OF CHONGQING MEDICAL UNIVERSITY, THE FIRST AFFILIATED HOSPITAL OF XIAMEN UNIVERSITY, THE FIRST AFFILIATED HOSPITAL WITH NANJING MEDICAL UNIVESITY, THE FIRST HOSPITAL AFFILIATED TO AMU (SOUTHWEST HOSPITAL), THE FIRST HOSPITAL OF LANZHOU UNIVERSITY, THE FIRST HOSPITAL OF ZHEJIANG PROVINCE, THE FIRST PEOPLE'S HOSPITAL OF YUEYANG, THE NORTHERN JIANGSU PEOPLES HOSPITAL, THE PEOPLE'S HOSPITAL OF GUANGXI ZHUANG AUTONOMOUS REGION, THE SECOND AFFILIATED HOSPITAL OF GUANGXI MEDICAL UNIVERSITY, THE SECOND AFFILIATED HOSPITAL OF ZHENGZHOU UNIVERSITY, THE SECOND AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY SCHOOL OF MEDICINE, THE SECOND HOSPITAL OF JILIN UNIVERSITY, THE SECOND XIANGYA HOSPITAL OF CENTRAL SOUTH UNIVERSITY, THE SIXTH MEDICAL CENTER OF PLA GENERAL HOSPITAL, THE THIND AFFILIATED HOSPITAL OF XINJIANG MEDICAL UNIVERSITY, WEST CHINA HOSPITAL，SICHUAN UNIVERSITY, WUHAN ASIA HEART HOSPITAL, WUHAN JINYINTAN HOSPITAL, WUHAN UNION HOSPITAL, XIANGYIA HOSPITAL CENTRAL SOUTH UNIVERSITY, XIJING HOSPITAL, ZHEJIANG PROVINCE PEOPLE'S HOSPITAL, ZHON GNAN HOSPITAL OF WUHAN UNIVERSITY, ZHONGDA HOSPITAL SOUTHEAST UNIVERSITY, ZHONGSHAN HOSPITAL

• Study Type: Observational
• Enrollment (Estimated): 20000

Contacts and Locations

• Study Contact: Name: Xiaotong Hou, MD., PhD.; Phone Number: 8610 64456631; Email: xt.hou@ccmu.edu.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University
      • Contact: Xiaotong Hou, MD., PhD.; Phone Number: 8610 64456631; Email: xt.hou@ccmu.edu.cn
      • Principal Investigator: Xiaotong Hou, MD., PhD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients receiving ECMO for circulatory and/or respiratory support

Description

Inclusion Criteria:

• Patients receiving ECMO for circulatory and/or respiratory support

Exclusion Criteria:

• Refusal of consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary Support; ECMO support for acute respiratory failure, ARDS	Device: ECMO; ECMO for circulatory and/or respiratory support
Cardiac Support; ECMO support for heart failure, cardiogenic shock	Device: ECMO; ECMO for circulatory and/or respiratory support
Extracorporeal Cardiopulmonary Resuscitation; ECMO support for cardia arrest	Device: ECMO; ECMO for circulatory and/or respiratory support

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
All-cause mortality	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality		365 days
Rate of successful weaning from ECMO		30 days
ECMO-related complications	Bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change	30 days
Other complications	Acute renal failure, ulcer bleeding, pneumonia, sepsis	30 days
Duration stay at ICU and hospital		365 days

Collaborators and Investigators

• Sponsor: Beijing Anzhen Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: November 7, 2019
• First Submitted That Met QC Criteria: November 7, 2019
• First Posted (Actual): November 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 7, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Shock; Myocardial Infarction; Infarction; Lung Injury; Infant, Premature, Diseases; Respiratory Insufficiency; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury; Shock, Cardiogenic
• Other Study ID Numbers: 2019040X

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No