Integration of Minimal Invasive Cardiopulmonary Bypass System and the Research of Its Blood Compatibility

NCT04476342 | Unknown DMC

• 1 other identifier: 2019-044
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Research objective: (1) To develop a minimally invasive extracorporeal circulation integrated system, and to form a new product package, the package of the system should include the extracorporeal circulation off-set supplies for a routine heart operation.(2) To explore the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients.(3) To explore the influence of integrated minimally invasive extracorporeal circulation system on blood dilution of patients.(4) To explore the influence of integrated minimally invasive extracorporeal circulation system on inflammatory response in patients. 1\) Clinical research methods: A prospective, single-blind, randomized controlled study was designed. 80 patients should be included.Clinical study grouping: The control group was conventional cardiopulmonary bypass (CCPB) group, which was equipped with ordinary oxygenator, microemboli filter and 4:1 cardioplegia solution.The experimental group was minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% potassium chloride (KCl)+10ml compound potassium, calcium and magnesium +25ml normal saline). Research method: A: Before, in, and after cardiopulmonary bypass (CPB) blood collection, Hemoglobin (Hb), hematokrit (Hct), and blood lactate values of the two groups of patients were measured and analyzed statistically.B: Blood transfusion volume, urine volume and ultrafiltration volume were collected during CPB in the two groups of patients, and the data of the two groups were statistically analyzed.To investigate the effects of integrated minimally invasive extracorporeal circulation system on inflammatory response indicators white blood cell count (WBC),C-reactive protein (CRP), interleukin-6(IL-6), tumor necrosis factor-a (TNF-a) and C3a in patients before (T0), CPB (T1) and 2 hours(H) after CPB (T2), blood samples were collected from the two groups, centrifugated, superfluid was taken, and stored at -80℃.The concentrations of CRP, IL-6, TNF-a and C3a were determined by ELISA.Statistical analysis was performed.WBC was measured in blood routine.(3) To investigate the influence of integrated minimally invasive extracorporeal circulation system on the recent clinical outcome of patients. The mechanical ventilation time, ICU time, length of hospital stay, and in-hospital mortality of patients in the two groups were statistically analyzed.

Conditions

Cardiopulmonary Bypass; Cardiac Surgery

Keywords

cardiopulmonary bypass; minimal invasive; cardiac surgery; blood compatibility

Outcome Measures

Primary Outcomes (1)

• Blood transfusion volume

  Blood transfusion volume during cardiac surgery

  through surgery completion, an average of 5 hours

Secondary Outcomes (1)

• ICU duration

  Duration of ICU stay, an average of 3 days

Study Arms (2)

MICPB group

EXPERIMENTAL

The experimental group is minimal invasive cardiopulmonary bypass (MICPB) group, with built-in micro-thrombotic oxygenator and mini cardioplegia (MP) formula (15ML15% KCl+10ml compound potassium, calcium and magnesium +25ml normal saline).

Device: minimal invasive cardiopulmonary bypass (MICPB) system

CCPB group

NO INTERVENTION

The control group was conventional cardiopulmonary bypass (CCPB) group, using ordinary oxygenator, microemboli filter, and 4:1 cardioplegia solution.

Interventions

minimal invasive cardiopulmonary bypass (MICPB) system DEVICE

The experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15mL 15%KCl+10ml compound potassium, calcium and magnesium +25ml normal saline)

MICPB group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient weight ≤60kg;
• Age ≥18 years old;
• The patient underwent cardiac arrest surgery.

You may not qualify if:

• Heart transplant patients;
• Emergency cardiac surgery patients;
• Patients who had been assisted by extracorporeal membrane oxygenator (ECMO) or assisted by left heart before operation
• Left ventricular ejection fraction (LVEF) \< 30%;
• Patients with coagulation dysfunction before surgery;
• Patients with preoperative hepatic and renal insufficiency;
• Recent cerebrovascular accident patients.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Central Study Contacts

Anqi Li, master

CONTACT

86-13706719453; 13706719453@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 20, 2020
• Study Start: June 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: July 20, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)