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

Primary Purpose

Anemia, Cognitive; Disorder, Due to General Medical Condition, Embolism, Air

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
HAR
Sponsored by
Juan Blanco Morillo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia focused on measuring Retrograde autologous priming, RAP, HAR, cardiopulmonary bypass, Extracorporeal circulation, Gaseous microemboli, perfusion

Eligibility Criteria

50 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Clinico universitario Virgen de la Arrixaca

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

HAR group

Control Group

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Emboli number
Number of total gaseous microemboli delivered by the extracorporeal system to the patient
Emboli Volume
Volume of total gaseous microemboli delivered by the extracorporeal system to the patient
Emotional regulation
Evolution of Emotional regulation test results, comparing the variation with the amount of embolic events detected during the extracorporeal procedure. (4-6 months)
Visual work memory variation and emboli
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.
Executive functions and emboli
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
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

Full Information

First Posted
October 18, 2018
Last Updated
February 9, 2021
Sponsor
Juan Blanco Morillo
Collaborators
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca
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1. Study Identification

Unique Protocol Identification Number
NCT03720184
Brief Title
Haemo-autologous Antegrade Repriming (HAR) as Minimum Impact Perfusion Strategy for Cardiopulmonary Bypass
Acronym
HARjbm1
Official Title
Haemo-autologous Antegrade Repriming (HAR) Clinical Trial for Validation as Minimum Impact Perfusion Strategy in Cardiopulmonary Bypass
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
August 15, 2018 (Actual)
Primary Completion Date
September 1, 2019 (Actual)
Study Completion Date
February 9, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Juan Blanco Morillo
Collaborators
Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Cognitive; Disorder, Due to General Medical Condition, Embolism, Air, Transfusion, Cardiac Disease, Extracorporeal Circulation; Complications, Valve Anomalies
Keywords
Retrograde autologous priming, RAP, HAR, cardiopulmonary bypass, Extracorporeal circulation, Gaseous microemboli, perfusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
116 (Actual)

8. Arms, Groups, and Interventions

Arm Title
HAR group
Arm Type
Experimental
Arm 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
Arm Title
Control Group
Arm Type
No Intervention
Arm 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
Intervention Type
Procedure
Intervention Name(s)
HAR
Other Intervention Name(s)
Haematic antegrade repriming, Extracorporeal circuit repriming
Intervention Description
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
Primary Outcome Measure Information:
Title
Transfusion
Description
Blood product consumption during patients hospital stay
Time Frame
1 year
Title
ICU stay
Description
Length of stay at Intensive Care Unit. (days)
Time Frame
1 year
Title
Ventilation time
Description
Hours under mechanical ventilation after surgery
Time Frame
1 year
Title
Complications
Description
Incidence of neurological, respiratory, urinary, cardiologic complications and multiorganic failure
Time Frame
1 year
Title
Mortality
Description
Incidence of death during hospital stay
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Emboli number
Description
Number of total gaseous microemboli delivered by the extracorporeal system to the patient
Time Frame
1 year
Title
Emboli Volume
Description
Volume of total gaseous microemboli delivered by the extracorporeal system to the patient
Time Frame
1 year
Title
Emotional regulation
Description
Evolution of Emotional regulation test results, comparing the variation with the amount of embolic events detected during the extracorporeal procedure. (4-6 months)
Time Frame
6 months after surgery
Title
Visual work memory variation and emboli
Description
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.
Time Frame
6 months after surgery
Title
Executive functions and emboli
Description
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
Time Frame
6 months after surgery
Title
Visual memory and cognitive status evaluation and emboli
Description
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
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan B Morillo, M.Sc
Organizational Affiliation
IMIB. University Hospital Virgen de la Arrixaca. Murcia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinico universitario Virgen de la Arrixaca
City
Murcia
State/Province
MU
ZIP/Postal Code
30011
Country
Spain

12. IPD Sharing Statement

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Links:
URL
https://doi.org/10.1186/1471-2377-11-92
Description
To assess and compare the effectiveness and costs of Phototest,Screen for dementia (DEM) and cognitive impairment (CI).
URL
http://linkinghub.elsevier.com/retrieve/pii/S0003497502037669
Description
Effect of blood transfusion on long-term survival after cardiac operation

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

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