NCT04476342: IMICPBS

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

Status unknown NA Last updated 20 July 2020

What this trial tests

NA trial testing minimal invasive cardiopulmonary bypass (MICPB) system in Cardiopulmonary Bypass in 80 participants. Status unknown.

Timeline

1 June 2019

Primary endpoint
31 December 2020

31 December 2021

Quick facts

Lead sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	80
Start date	1 June 2019
Primary completion	31 December 2020
Estimated completion	31 December 2021
Sites	1 location across China

Drugs / interventions tested

• minimal invasive cardiopulmonary bypass (MICPB) system

Conditions studied

• Cardiopulmonary Bypass — all drugs for Cardiopulmonary Bypass →
• Cardiac Surgery — all drugs for Cardiac Surgery →

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Who can join

Adults 18 to 80, any sex, with Cardiopulmonary Bypass or Cardiac Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.