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Completed

NCT Number: NCT03720184

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

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.

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Key information

Conditions

Anemia Cardiac Disease Cardiovascular Diseases Cognitive; Disorder, Due to General Medical Condition Embolism Embolism and Thrombosis Embolism, Air Extracorporeal Circulation; Complications Heart Diseases Hematologic Diseases Hemic and Lymphatic Diseases Transfusion Valve Anomalies Vascular Diseases

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clinico universitario Virgen de la Arrixaca

Murcia, MU, 30011, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HAR

Procedure

HAR, the 6 steps procedure that results in 300ml of haemodilution. Step 0: Circuit is primed with 1000ml of crystalloid solution. Step 1: Venous line content is drained to the reservoir. Step 2: arterial srystalloid priming is displaced to the reservoir retrogradely by autologous blood. Step 3: Crystalloid priming is discarded to the collector bag. Step 4: An amount of 300ml of arterial blood is sequestered to the reservoir avoiding the mixture. Step 5: The centrifugal pump and the oxygenator are reprimed with autologous blood displacing the priming and GME to the collector bag. Step 6: CPB is initiated with a low haemodilution of 300ml.

Available at: https://zenodo.org/record/4276132#.X7K8AchKgRk

Other names: Haematic antegrade repriming, Extracorporeal circuit repriming

Primary outcomes

  1. Transfusion

    Time frame: 1 year

    Blood product consumption during patients hospital stay

  2. ICU stay

    Time frame: 1 year

    Length of stay at Intensive Care Unit. (days)

  3. Ventilation time

    Time frame: 1 year

    Hours under mechanical ventilation after surgery

  4. Complications

    Time frame: 1 year

    Incidence of neurological, respiratory, urinary, cardiologic complications and multiorganic failure

  5. Mortality

    Time frame: 1 year

    Incidence of death during hospital stay

Secondary outcomes

  1. Emboli number

    Time frame: 1 year

    Number of total gaseous microemboli delivered by the extracorporeal system to the patient

  2. Emboli Volume

    Time frame: 1 year

    Volume of total gaseous microemboli delivered by the extracorporeal system to the patient

  3. Emotional regulation

    Time frame: 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)

  4. Visual work memory variation and emboli

    Time frame: 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.

  5. Executive functions and emboli

    Time frame: 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

  6. Visual memory and cognitive status evaluation and emboli

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Juan Blanco Morillo

Other

Collaborators

  • Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Registry information

Official study title

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

Acronym: HARjbm1

Important dates

Study start
2018
Primary completion
2019
Study completion
2021
First posted
Oct 25, 2018
Registry last updated
Feb 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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