Haemo-autologous Antegrade Repriming (HAR) as Minimum Impact Perfusion Strategy for Cardiopulmonary Bypass (HARjbm1)

Juan Blanco Morillo

Status: Completed

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

Treatments: Procedure: HAR

Study type: Interventional

Funder types: Other

Identifiers

NCT03720184

HARjbm1

Details and patient eligibility

About

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.

Full 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

Enrollment: 116 patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

116 participants in 2 patient groups

HAR group

Experimental group

Description:

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

Treatment:

Procedure: HAR

Control Group

No Intervention group

Description:

Control group is not exposed to HAR. The extracorporeal circuit is a MiECC primed with 1000ml of Isofundin (crystalloid balanced solution) as an standard circuit