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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03720184
Recruitment Status : Completed
First Posted : October 25, 2018
Last Update Posted : February 12, 2021
Sponsor:
Collaborator:
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Information provided by (Responsible Party):
Juan Blanco Morillo, Hospital Universitario Virgen de la Arrixaca

Study Description
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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.


Condition or disease Intervention/treatment Phase
Anemia Cognitive; Disorder, Due to General Medical Condition Embolism, Air Transfusion Cardiac Disease Extracorporeal Circulation; Complications Valve Anomalies Procedure: HAR Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 116 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

In a preliminary phase, patients are randomly assigned to 4 branches, regarding to two conditions: oxygenator´s deairing type and HAR exposure. This phase is designed as pilot study with 100 patients in order to determine precisely the sample size needed depending on the observed effects.

If there are no clinical differences between oxygenators behaviour, during the second stage, sample will be only divided in 2 groups due to HAR exposure.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:

Patient and neurocognitive examinator does not know the arm assigned, as well as the anaesthesiologist, surgeon and ICU team. Only the perfusionist has access to de randomization sheet before choosing and set up of the extracorporeal circuit.

In order to guarantee the blinding, the perfusionist must be hidden during the possible HAR performance, using a field blanket to isolate the oxygenator´s area. Anestesiologist´s proceed in every case as if HAR is assigned maintaining a mean arterial pressure over 60 mmHg.
Primary Purpose: Treatment
Official Title: Haemo-autologous Antegrade Repriming (HAR) Clinical Trial for Validation as Minimum Impact Perfusion Strategy in Cardiopulmonary Bypass
Actual Study Start Date : August 15, 2018
Actual Primary Completion Date : September 1, 2019
Actual Study Completion Date : February 9, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: HAR group
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
 Procedure: HAR

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
No Intervention: Control Group
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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03720184


Locations
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Spain
Hospital Clinico universitario Virgen de la Arrixaca
Murcia, MU, Spain, 30011
Sponsors and Collaborators
Juan Blanco Morillo
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
Investigators
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Principal Investigator: Juan B Morillo, M.Sc IMIB. University Hospital Virgen de la Arrixaca. Murcia
More Information
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Additional Information:

Publications of Results:

Other Publications:

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Responsible Party: Juan Blanco Morillo, Principal Investigator, Hospital Universitario Virgen de la Arrixaca
ClinicalTrials.gov Identifier: NCT03720184    
Other Study ID Numbers: HARjbm1
First Posted: October 25, 2018    Key Record Dates
Last Update Posted: February 12, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan Blanco Morillo, Hospital Universitario Virgen de la Arrixaca:
Retrograde autologous priming
RAP
HAR
cardiopulmonary bypass
 Extracorporeal circulation
Gaseous microemboli
perfusion
Additional relevant MeSH terms:
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Embolism
Heart Diseases
Embolism, Air
Cognition Disorders
Embolism and Thrombosis
 Vascular Diseases
Cardiovascular Diseases
Neurocognitive Disorders
Mental Disorders