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AnemiaHARjbm1NCT03720184

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

A study testing HAR in people with Anemia and Cognitive; Disorder, Due to General Medical Condition, run by Juan Blanco Morillo at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 50 to 99 years
What is being tested?
HAR
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteSpain
Study dates
15 Aug 2018to 9 Feb 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Urgency and emergency
  • Heart transplantations
  • Severe cognitive affection
  • Active sepsis
  • Previous anemia
  • Early re-intervention
Show all 9Show fewer
  • Pre-Op extracorporeal membrane oxygenation (ECMO) support
  • Hemodynamic unstability during HAR
  • Any clinical condition that may force protocol deviation

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clinico universitario Virgen de la Arrixaca

    Murcia, MU, 30011

Other trials in Spain

About this study

Official title: Haemo-autologous Antegrade Repriming (HAR) Clinical Trial for Validation as Minimum Impact Perfusion Strategy in 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.

Read the 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

Being tested
HAR
Keywords
Retrograde autologous priming, RAP, HAR, cardiopulmonary bypass, Extracorporeal circulation, Gaseous microemboli, perfusion
Medical subject headings
Anemia, Embolism, Air, Heart Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HARProcedure or surgery

    Also called Haematic antegrade repriming, Extracorporeal circuit repriming

    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

Study groups in NCT03720184
Study groupRoleWhat they receive
HAR groupExperimentalTreated 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
Receives: Procedure: HAR
Control GroupNo interventionControl group is not exposed to HAR. The extracorporeal circuit is a MiECC primed with 1000ml of Isofundin (crystalloid balanced solution) as an standard circuit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Transfusion

    Blood product consumption during patients hospital stay

    Measured: 1 year

  2. ICU stay

    Length of stay at Intensive Care Unit. (days)

    Measured: 1 year

  3. Ventilation time

    Hours under mechanical ventilation after surgery

    Measured: 1 year

  4. Complications

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

    Measured: 1 year

  5. Mortality

    Incidence of death during hospital stay

    Measured: 1 year

Secondary outcomes (6)

  1. Emboli number

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

    Measured: 1 year

  2. Emboli Volume

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

    Measured: 1 year

  3. 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)

    Measured: 6 months after surgery

  4. 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.

    Measured: 6 months after surgery

  5. 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

    Measured: 6 months after surgery

  6. 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

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2018
  2. Study start15 Aug 2018
  3. Primary completion1 Sep 2019
  4. Study completion9 Feb 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03720184
Sponsor's protocol ID
HARjbm1
Acronym
HARjbm1
Status last verified
Feb 2021
First submitted
18 Oct 2018
Last updated
12 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 23998782

  • 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.

    PubMed 19762724

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

    PubMed 19192754

  • 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.

    PubMed 21474666

  • 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.

    PubMed 24570589

  • 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.

    PubMed 28766987

  • 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.

    PubMed 29397361

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

    PubMed 15161064

  • 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.

    PubMed 23482374

  • 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.

    PubMed 26053122

  • 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.

    PubMed 20197351

  • 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.

    PubMed 27283935

  • 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.

    PubMed 28193536

  • 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.

    PubMed 21353044

Questions about this trial

What is this clinical trial studying?

A study testing HAR in people with Anemia and Cognitive; Disorder, Due to General Medical Condition, run by Juan Blanco Morillo at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Transfusion (time frame: 1 year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03720184, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2021.

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