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

Anemia Clinical Trial

— HARjbm1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03720184
• Other study ID #: HARjbm1
• Status: Completed
• Phase: N/A
• Start date: August 15, 2018
• Est. completion date: February 9, 2021

Study information

• Verified date: February 2021
• Source: Hospital Universitario Virgen de la Arrixaca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: February 9, 2021
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Cardiac Disease
• Cognition Disorders
• Cognitive; Disorder, Due to General Medical Condition
• Embolism
• Embolism, Air
• Extracorporeal Circulation; Complications
• Heart Diseases
• Transfusion
• Valve Anomalies

Intervention

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

Locations

Country	Name	City	State
Spain	Hospital Clinico universitario Virgen de la Arrixaca	Murcia	MU

Sponsors (2)

Lead Sponsor	Collaborator
Juan Blanco Morillo	Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca

Country where clinical trial is conducted

Spain, 

References & Publications (14)

Abrahamov D, Levran O, Naparstek S, Refaeli Y, Kaptson S, Abu Salah M, Ishai Y, Sahar G. Blood-Brain Barrier Disruption After Cardiopulmonary Bypass: Diagnosis and Correlation to Cognition. Ann Thorac Surg. 2017 Jul;104(1):161-169. doi: 10.1016/j.athoracs — View Citation

Basciani R, Kröninger F, Gygax E, Jenni H, Reineke D, Stucki M, Hagenbuch N, Carrel T, Eberle B, Erdoes G. Cerebral Microembolization During Aortic Valve Replacement Using Minimally Invasive or Conventional Extracorporeal Circulation: A Randomized Trial. — View Citation

De Somer FM, Vetrano MR, Van Beeck JP, Van Nooten GJ. Extracorporeal bubbles: a word of caution. Interact Cardiovasc Thorac Surg. 2010 Jun;10(6):995-1001. doi: 10.1510/icvts.2009.229088. Epub 2010 Mar 2. — View Citation

Evered L, Scott DA, Silbert B, Maruff P. Postoperative cognitive dysfunction is independent of type of surgery and anesthetic. Anesth Analg. 2011 May;112(5):1179-85. doi: 10.1213/ANE.0b013e318215217e. Epub 2011 Apr 7. — View Citation

Kurusz M, Butler BD. Bubbles and bypass: an update. Perfusion. 2004;19 Suppl 1:S49-55. Review. — View Citation

Lazar RM, Pavol MA, Bormann T, Dwyer MG, Kraemer C, White R, Zivadinov R, Wertheimer JC, Thöne-Otto A, Ravdin LD, Naugle R, Mechanic-Hamilton D, Garmoe WS, Stringer AY, Bender HA, Kapadia SR, Kodali S, Ghanem A, Linke A, Mehran R, Virmani R, Nazif T, Parhizgar A, Leon MB. Neurocognition and Cerebral Lesion Burden in High-Risk Patients Before Undergoing Transcatheter Aortic Valve Replacement: Insights From the SENTINEL Trial. JACC Cardiovasc Interv. 2018 Feb 26;11(4):384-392. doi: 10.1016/j.jcin.2017.10.041. Epub 2018 Feb 1. — View Citation

Liu YH, Wang DX, Li LH, Wu XM, Shan GJ, Su Y, Li J, Yu QJ, Shi CX, Huang YN, Sun W. The effects of cardiopulmonary bypass on the number of cerebral microemboli and the incidence of cognitive dysfunction after coronary artery bypass graft surgery. Anesth Analg. 2009 Oct;109(4):1013-22. doi: 10.1213/ane.0b013e3181aed2bb. — View Citation

Loor G, Rajeswaran J, Li L, Sabik JF 3rd, Blackstone EH, McCrae KR, Koch CG. The least of 3 evils: exposure to red blood cell transfusion, anemia, or both? J Thorac Cardiovasc Surg. 2013 Dec;146(6):1480-1487.e6. doi: 10.1016/j.jtcvs.2013.06.033. Epub 2013 Aug 30. — View Citation

Segers T, Stehouwer MC, de Somer FMJJ, de Mol BA, Versluis M. Optical verification and in-vitro characterization of two commercially available acoustic bubble counters for cardiopulmonary bypass systems. Perfusion. 2018 Jan;33(1):16-24. doi: 10.1177/0267659117722595. Epub 2017 Aug 2. — View Citation

Society of Thoracic Surgeons Blood Conservation Guideline Task Force, Ferraris VA, Brown JR, Despotis GJ, Hammon JW, Reece TB, Saha SP, Song HK, Clough ER; Society of Cardiovascular Anesthesiologists Special Task Force on Blood Transfusion, Shore-Lesserso — View Citation

Spellman T, Rigotti M, Ahmari SE, Fusi S, Gogos JA, Gordon JA. Hippocampal-prefrontal input supports spatial encoding in working memory. Nature. 2015 Jun 18;522(7556):309-14. doi: 10.1038/nature14445. Epub 2015 Jun 8. — View Citation

Vandewiele K, Bové T, De Somer FM, Dujardin D, Vanackere M, De Smet D, Moerman AT, Bouchez S, François K. The effect of retrograde autologous priming volume on haemodilution and transfusion requirements during cardiac surgery. Interact Cardiovasc Thorac S — View Citation

Wang S, Undar A. Vacuum-assisted venous drainage and gaseous microemboli in cardiopulmonary bypass. J Extra Corpor Technol. 2008 Dec;40(4):249-56. Review. — View Citation

Zhang X, Yan X, Gorman J, Hoffman SN, Zhang L, Boscarino JA. Perioperative hyperglycemia is associated with postoperative neurocognitive disorders after cardiac surgery. Neuropsychiatr Dis Treat. 2014 Feb 19;10:361-70. doi: 10.2147/NDT.S57761. eCollection 2014. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transfusion	Blood product consumption during patients hospital stay	1 year
Primary	ICU stay	Length of stay at Intensive Care Unit. (days)	1 year
Primary	Ventilation time	Hours under mechanical ventilation after surgery	1 year
Primary	Complications	Incidence of neurological, respiratory, urinary, cardiologic complications and multiorganic failure	1 year
Primary	Mortality	Incidence of death during hospital stay	1 year
Secondary	Emboli number	Number of total gaseous microemboli delivered by the extracorporeal system to the patient	1 year
Secondary	Emboli Volume	Volume of total gaseous microemboli delivered by the extracorporeal system to the patient	1 year
Secondary	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)	6 months after surgery
Secondary	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.	6 months after surgery
Secondary	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	6 months after surgery
Secondary	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	6 months after surgery

External Links

•   Effect of blood transfusion on long-term survival after cardiac operation
•   Effect of blood transfusion on long-term survival after cardiac operation - The Annals of Thoracic Surgery
•   Postoperative cognitive dysfunction is receiving increasing attention, particularly cognitive deficits after cardiac surgery
•   To assess and compare the effectiveness and costs of Phototest,Screen for dementia (DEM) and cognitive impairment (CI).