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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04158479
Other study ID # 2019040X
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date December 31, 2030

Study information

Verified date April 2024
Source Beijing Anzhen Hospital
Contact Xiaotong Hou, MD., PhD.
Phone 8610 64456631
Email xt.hou@ccmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 20000
Est. completion date December 31, 2030
Est. primary completion date December 31, 2030
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients receiving ECMO for circulatory and/or respiratory support Exclusion Criteria: - Refusal of consent

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ECMO
ECMO for circulatory and/or respiratory support

Locations

Country Name City State
China Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

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