Clinical Study of Mechanical Circulatory Support for Cardiogenic Shock — A Prospective Randomized Controlled Study of the Clinical Efficacy of ECMO and Extracorporeal Left Ventricular Assist Device

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400087282

Enrollment

Unknown

Registered

2024-07-24

Start date

2024-08-01

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical cardiovascular diseases

Interventions

Control group:Continuous support is provided throughout the entire duration utilizing VA-ECMO/VA-ECMO+IABP

Experimental group:Within 24 hours of the initiation of V-A ECMO life support, the transition to Extra-VAD life support is supported by DSA and other auxiliary devices

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Participants have a confirmed clinical diagnosis of cardiogenic shock; 2. Aged between 18 and 80 years, regardless of gender; 3. Participants are fully informed and have obtained written informed consent;

Exclusion criteria

Exclusion criteria: 1. Severe, irreversible chronic non-cardiac organ failure limiting survival; 2. Irreversible heart failure; 3. Aortic dissection; 4. ECPR; 5. Patients with severe respiratory failure; 6. Right heart failure in patients (TAPSE < 1.2cm); 7. Patients who refuse to participate in this study, refusing to be enrolled.

Design outcomes

Primary

Measure	Time frame
The mortality rate 30 days after the removal of the mechanical assist device;	—

Secondary

Measure	Time frame
The rate of occurrence of bleeding events;The incidence rate of infection events;The occurrence rate of renal function failure;The incidence rate of thrombotic events;Echocardiography(LVEF, EDV, ESV, EF, VTI, TAPSE, TDI);Myocardial Enzyme(such as cTnI/hs-cTnI,BNP/NT-proBNP,CK/CKMB);Major adverse cardiovascular events (death, acute myocardial infarction, malignant arrhythmias, acute heart failure, rehospitalization due to heart failure);Coagulation function (activated partial thromboplastin time (APTT), prothrombin time (PT), international normalized ratio (INR), fibrinogen (FIB), D-dimer (DD), with APTT and DD being mandatory tests);Blood biochemistry (total bilirubin, direct bilirubin, indirect bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), serum creatinine (Scr), urea or blood urea nitrogen (BUN), electrolytes (such as K+));Complete blood count: red blood cell (RBC) count, white blood cell (WBC) count, platelet (PLT) count, neutrophil count, hemoglobin (Hb).;Urinalysis: urine color, urinary red blood cells, urinary occult blood, urinary urobilinogen, urinary white blood cells, urinary protein;The duration of mechanical circulatory support;Electrocardiogram ;	—

Measure

Time frame

The rate of occurrence of bleeding events;The incidence rate of infection events;The occurrence rate of renal function failure;The incidence rate of thrombotic events;Echocardiography(LVEF, EDV, ESV, EF, VTI, TAPSE, TDI);Myocardial Enzyme(such as cTnI/hs-cTnI,BNP/NT-proBNP,CK/CKMB);Major adverse cardiovascular events (death, acute myocardial infarction, malignant arrhythmias, acute heart failure, rehospitalization due to heart failure);Coagulation function (activated partial thromboplastin time (APTT), prothrombin time (PT), international normalized ratio (INR), fibrinogen (FIB), D-dimer (DD), with APTT and DD being mandatory tests);Blood biochemistry (total bilirubin, direct bilirubin, indirect bilirubin, alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), serum creatinine (Scr), urea or blood urea nitrogen (BUN), electrolytes (such as K+));Complete blood count: red blood cell (RBC) count, white blood cell (WBC) count, platelet (PLT) count, neutrophil count, hemoglobin (Hb).;Urinalysis: urine color, urinary red blood cells, urinary occult blood, urinary urobilinogen, urinary white blood cells, urinary protein;The duration of mechanical circulatory support;Electrocardiogram ;

—

Countries

China

Contacts

Public ContactMing Bai

The First Hospital of Lanzhou University

baiming@vip.163.com+86 138 9322 0909

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026