Haemo-autologous Antegrade Repriming (HAR) as Minimum Impact Perfusion Strategy for Cardiopulmonary Bypass

Not Applicable

Completed

• Conditions: Embolism, Air; Valve Anomalies; Anemia; Cardiac Disease; Transfusion; Extracorporeal Circulation; Complications; Cognitive; Disorder, Due to General Medical Condition
• Interventions: Procedure: HAR

• Registration Number: NCT03720184
• Lead Sponsor: Juan Blanco Morillo

Brief Summary

Haemo-autologous Antegrade Repriming (HAR) is a procedure based in the combination of evidence proven measures designed to reduce the haemodilution caused by establishing the cardiopulmonary bypass (CPB) during cardiac surgery.

This clinical trial aims to determinate, in one hand, the benefits related to HAR in terms of transfusion, ICU stay, ventilation time, early mortality and complications. In the other hand analyzes the gaseous microemboli (GME) load, comparing the oxygenators venting technology´s efficiency in treatment and control group, and its relation with patient´s neurocognitive status.

Detailed Description

HAR is a repriming technique based in Retrograde Autologous Priming (RAP), that has been implemented by recently recommended measures in terms of reducing blood transfusions.

The expected clinical benefits are related to hemodilution´s reduction up to only 300ml. The extracorporeal circuit has been reduced to 3/8 inch diameter in both lines, reducing the surface up to 1000ml of dynamic priming.

Vacuum assisted venous drainage (VAVD) allows to empty the venous line after priming and deairing, facilitating the venous flow for CPB initiation.

The antegrade repriming eliminates the maximum amount of crystalloid contained in the circuit, displacing it to a collector bag, by using autologous blood sequestered from the arterial line to the hardshell reservoir.

HAR reduces the CPB hemodilution related to priming from 1500 to 300 ml preventing the usual sudden haemoglobin level reduction occured during every extracorporeal techinque´s establishment.

Our mission is to analyze if HAR can be validated as a safe and effective tool to improve clinical outcomes in cardiac surgery procedures under extracorporeal circulation

Study Timeline

• Study Start: 2018-08-15
• Study First Submitted: 2018-10-18
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Primary Completion: 2019-09-01
• Status Verified: 2021-02
• Study Completion: 2021-02-09
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• All patients purposed to undergo elective cardiopulmonary bypass for cardiac valve surgery or other pathologies requiring to open heart chambers.

Exclusion Criteria

• Urgency and emergency
• Heart transplantations
• Severe cognitive affection
• Active sepsis
• Previous anemia
• Early re-intervention
• Pre-Op extracorporeal membrane oxygenation (ECMO) support
• Hemodynamic unstability during HAR
• Any clinical condition that may force protocol deviation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HAR group	HAR	Treated group is exposed to an haematic antegrade autologous repriming of the MiECC CLass IV circuit, reducing the haemodilution related to CPB initiation to a fix amount of 300ml

Primary Outcome Measures

Name	Time	Method
Transfusion	1 year	Blood product consumption during patients hospital stay
ICU stay	1 year	Length of stay at Intensive Care Unit. (days)
Ventilation time	1 year	Hours under mechanical ventilation after surgery
Complications	1 year	Incidence of neurological, respiratory, urinary, cardiologic complications and multiorganic failure
Mortality	1 year	Incidence of death during hospital stay

Secondary Outcome Measures

Name	Time	Method
Emboli number	1 year	Number of total gaseous microemboli delivered by the extracorporeal system to the patient
Visual work memory variation and emboli	6 months after surgery	Evolution of Visuospatial working memory test results, comparing the variation of the basal status and short term measurements (4-6 months after surgery) with the amount of detected emboli delivered to the patient through the heart-lung machine´s circuit.
Emboli Volume	1 year	Volume of total gaseous microemboli delivered by the extracorporeal system to the patient
Emotional regulation	6 months after surgery	Evolution of Emotional regulation test results, comparing the variation with the amount of embolic events detected during the extracorporeal procedure. (4-6 months)
Executive functions and emboli	6 months after surgery	Analysis of the clock drawing test variation, comparing basal and short term (4-6 months after surgery) measurements, and the expected relation with the emboli detected during the extracorporeal technique
Visual memory and cognitive status evaluation and emboli	6 months after surgery	Analysis of the variation of cognitive functions using picture tests(comparing basal status and short term evaluation results (4-6 months after surgery) and the amount of emboli delivered to the patient during the cardiopulmonary bypass

Trial Locations

Locations (1)

Hospital Clinico universitario Virgen de la Arrixaca; 🇪🇸 Murcia, MU, Spain