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

NCT03720184 | Completed

• 1 other identifier: HARjbm1
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Transfusion

  Blood product consumption during patients hospital stay

  1 year

• ICU stay

  Length of stay at Intensive Care Unit. (days)

  1 year

• Ventilation time

  Hours under mechanical ventilation after surgery

  1 year

• Complications

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

  1 year

• Mortality

  Incidence of death during hospital stay

  1 year

Secondary Outcomes (6)

• Emboli number

  1 year

• Emboli Volume

  1 year

• Emotional regulation

  6 months after surgery

• Visual work memory variation and emboli

  6 months after surgery

• Executive functions and emboli

  6 months after surgery

Study Arms (2)

HAR group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

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

Also known as: Haematic antegrade repriming, Extracorporeal circuit repriming

HAR group

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients purposed to undergo elective cardiopulmonary bypass for cardiac valve surgery or other pathologies requiring to open heart chambers.

You may not qualify if:

• 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

Sponsors & Collaborators

• Juan Blanco Morillo: lead
• Instituto Murciano de Investigación Biosanitaria Virgen de la Arrixaca: collaborator

Study Sites (1)

Hospital Clinico universitario Virgen de la Arrixaca

Murcia, MU, 30011, Spain

Location

Related Publications (14)

• 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.

  PMID: 23998782 BACKGROUND

• 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.

  PMID: 19762724 BACKGROUND

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

  PMID: 19192754 BACKGROUND

• 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.

  PMID: 21474666 BACKGROUND

• 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.

  PMID: 24570589 BACKGROUND

• 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.

  PMID: 28766987 BACKGROUND

• Lazar RM, Pavol MA, Bormann T, Dwyer MG, Kraemer C, White R, Zivadinov R, Wertheimer JC, Thone-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.

  PMID: 29397361 BACKGROUND

• Kurusz M, Butler BD. Bubbles and bypass: an update. Perfusion. 2004;19 Suppl 1:S49-55. doi: 10.1191/0267659104pf720oa.

  PMID: 15161064 BACKGROUND

• Vandewiele K, Bove T, De Somer FM, Dujardin D, Vanackere M, De Smet D, Moerman AT, Bouchez S, Francois K. The effect of retrograde autologous priming volume on haemodilution and transfusion requirements during cardiac surgery. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):778-83. doi: 10.1093/icvts/ivt085. Epub 2013 Mar 12.

  PMID: 23482374 RESULT

• 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.

  PMID: 26053122 RESULT

• 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.

  PMID: 20197351 RESULT

• Basciani R, Kroninger 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. Artif Organs. 2016 Dec;40(12):E280-E291. doi: 10.1111/aor.12744. Epub 2016 Jun 10.

  PMID: 27283935 RESULT

• 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.athoracsur.2016.10.043. Epub 2017 Feb 10.

  PMID: 28193536 RESULT

• 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-Lesserson LJ, Goodnough LT, Mazer CD, Shander A, Stafford-Smith M, Waters J; International Consortium for Evidence Based Perfusion; Baker RA, Dickinson TA, FitzGerald DJ, Likosky DS, Shann KG. 2011 update to the Society of Thoracic Surgeons and the Society of Cardiovascular Anesthesiologists blood conservation clinical practice guidelines. Ann Thorac Surg. 2011 Mar;91(3):944-82. doi: 10.1016/j.athoracsur.2010.11.078.

  PMID: 21353044 RESULT

Related Links

• To assess and compare the effectiveness and costs of Phototest,Screen for dementia (DEM) and cognitive impairment (CI).
• Effect of blood transfusion on long-term survival after cardiac operation

MeSH Terms

Conditions

Anemia; Embolism, Air; Heart Diseases

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Juan B Morillo, M.Sc

  IMIB. University Hospital Virgen de la Arrixaca. Murcia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: October 18, 2018
• First Posted: October 25, 2018
• Study Start: August 15, 2018
• Primary Completion: September 1, 2019
• Study Completion: February 9, 2021
• Last Updated: February 12, 2021

Record last verified: 2021-02

Locations

ES (1)