## Protocol Section
### Identification Module
**NCT ID:** NCT04158479

**Brief Title:** China Extracorporeal Life Support Registry

**Official Title:** China Extracorporeal Life Support Registry

#### Organization Study ID Info
**ID:** 2019040X
#### Organization
**Class:** OTHER
**Full Name:** Beijing Anzhen Hospital
### Status Module
#### Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-04-09

**Type:** ACTUAL

**Last Update Submit Date:** 2024-04-07

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2030-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2017-01-01

**Type:** ACTUAL

**Status Verified Date:** 2024-04

#### Study First Post Date
**Date:** 2019-11-08
**Type:** ACTUAL
**Study First Submit Date:** 2019-11-07
**Study First Submit QC Date:** 2019-11-07
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Beijing Anzhen Hospital

#### Responsible Party

**Investigator Affiliation:** Beijing Anzhen Hospital

**Investigator Full Name:** Xiaotong Hou

**Investigator Title:** Chief, Center for Cardiac Intensive Care

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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.

**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

### Conditions Module

**Conditions:**

- Cardiogenic Shock

- Cardiac Arrest

- Heart Failure

- Acute Respiratory Distress Syndrome

- Acute Respiratory Failure

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 20000

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 1 Year

### Arms Interventions Module

#### Arm Group 1

**Description:** ECMO support for acute respiratory failure, ARDS

**Intervention Names:**

- Device: ECMO

**Label:** Pulmonary Support

#### Arm Group 2

**Description:** ECMO support for heart failure, cardiogenic shock

**Intervention Names:**

- Device: ECMO

**Label:** Cardiac Support

#### Arm Group 3

**Description:** ECMO support for cardia arrest

**Intervention Names:**

- Device: ECMO

**Label:** Extracorporeal Cardiopulmonary Resuscitation

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cardiac Support

- Extracorporeal Cardiopulmonary Resuscitation

- Pulmonary Support

**Description:** ECMO for circulatory and/or respiratory support

**Name:** ECMO

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Measure:** All-cause mortality

**Time Frame:** 30 days

#### Secondary Outcomes

**Measure:** All-cause mortality

**Time Frame:** 365 days

**Measure:** Rate of successful weaning from ECMO

**Time Frame:** 30 days

**Description:** Bleeding requiring transfusion or surgery, stroke, sepsis, limb ischemia requiring intervention, system or cannula change

**Measure:** ECMO-related complications

**Time Frame:** 30 days

**Description:** Acute renal failure, ulcer bleeding, pneumonia, sepsis

**Measure:** Other complications

**Time Frame:** 30 days

**Measure:** Duration stay at ICU and hospital

**Time Frame:** 365 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patients receiving ECMO for circulatory and/or respiratory support

Exclusion Criteria:

* Refusal of consent

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients receiving ECMO for circulatory and/or respiratory support

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** xt.hou@ccmu.edu.cn

**Name:** Xiaotong Hou, MD., PhD.

**Phone:** 8610 64456631

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Beijing

**Contacts:**

***Contact 1:***

- **Email:** xt.hou@ccmu.edu.cn

- **Name:** Xiaotong Hou, MD., PhD.

- **Phone:** 8610 64456631

- **Role:** CONTACT

***Contact 2:***

- **Name:** Xiaotong Hou, MD., PhD.

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** China

**Facility:** Center for Cardiac Intensive Care, Beijing Anzhen Hospital, Capital Medical University

**State:** Beijing

**Status:** RECRUITING

**Zip:** 100029

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000008171

- Term: Lung Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000012120

- Term: Respiration Disorders

- ID: D000007235

- Term: Infant, Premature, Diseases

- ID: D000007232

- Term: Infant, Newborn, Diseases

- ID: D000055370

- Term: Lung Injury

- ID: D000009203

- Term: Myocardial Infarction

- ID: D000017202

- Term: Myocardial Ischemia

- ID: D000014652

- Term: Vascular Diseases

- ID: D000007238

- Term: Infarction

- ID: D000007511

- Term: Ischemia

- ID: D000010335

- Term: Pathologic Processes

- ID: D000009336

- Term: Necrosis

- ID: D000012769

- Term: Shock

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC16

- Name: Diseases and Abnormalities at or Before Birth

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M14965

- Name: Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14964

- Name: Respiratory Distress Syndrome, Newborn

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: M14968

- Name: Respiratory Insufficiency

- Relevance: HIGH

- As Found: Respiratory Failure

- ID: M9421

- Name: Heart Failure

- Relevance: LOW

- As Found: Unknown

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M9411

- Name: Heart Arrest

- Relevance: LOW

- As Found: Unknown

- ID: M15577

- Name: Shock

- Relevance: LOW

- As Found: Unknown

- ID: M15578

- Name: Shock, Cardiogenic

- Relevance: HIGH

- As Found: Cardiogenic Shock

- ID: M28144

- Name: Acute Lung Injury

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: M28143

- Name: Lung Injury

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14957

- Name: Respiration Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M10279

- Name: Infant, Premature, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10276

- Name: Infant, Newborn, Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12155

- Name: Myocardial Infarction

- Relevance: LOW

- As Found: Unknown

- ID: M10282

- Name: Infarction

- Relevance: LOW

- As Found: Unknown

- ID: M10543

- Name: Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M6546

- Name: Coronary Artery Disease

- Relevance: LOW

- As Found: Unknown

- ID: M19506

- Name: Myocardial Ischemia

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12284

- Name: Necrosis

- Relevance: LOW

- As Found: Unknown

- ID: T4927

- Name: Respiratory Distress Syndrome, Infant

- Relevance: HIGH

- As Found: Respiratory Distress Syndrome

- ID: T192

- Name: Acute Respiratory Distress Syndrome

- Relevance: HIGH

- As Found: Acute Respiratory Distress Syndrome

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012128

- Term: Respiratory Distress Syndrome

- ID: D000012127

- Term: Respiratory Distress Syndrome, Newborn

- ID: D000012131

- Term: Respiratory Insufficiency

- ID: D000055371

- Term: Acute Lung Injury

- ID: D000012770

- Term: Shock, Cardiogenic

### Misc Info Module

- Version Holder: 2024-05-24
