NCT05699005

Brief Summary

This multicenter randomized controlled trial compare two transfusion strategies of red blood cells transfusion in patients supported by veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock. An individualized transfusion strategy based on ScVO2 level, is compared to a conventionnal strategy based on predefined hemoglobin threshold. The primary endpoint is the consumption of packed red blod cells, secondary endpoints are subgroup analysis, mortality, morbidity, and cost-effectiveness

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
238

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2023

Completed
8 months until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

April 4, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

December 21, 2022

Last Update Submit

April 3, 2024

Conditions

Cardiogenic ShockExtracorporeal Membrane OxygenationTransfusion Related ComplicationAnemiaOxygen Delivery

Keywords

ECMOECLSRefractory cardiogenic shockTransfusionScVO2Outcome

Outcome Measures

Primary Outcomes (1)

  • Number of PRBCs transfused per VA-ECMO day of support

    Total number of PRBCs transfused during support adjusted for VA- ECMO duration

    From randomisation until VA-ECMO weanning assessed up to 28 days

Secondary Outcomes (23)

  • Number of PRBCs transfused per VA-ECMO day of support in postcardiotomy patients

    From randomisation until VA-ECMO weanning assessed up to 28 days

  • Total number of PRBCs transfused during the 28-day following cannulation

    From randomisation until 28 days

  • Changes in hemoglobin levels during VA-ECMO support

    From randomisation until VA-ECMO weanning assessed up to 28 days

  • Changes in ScVO2 levels during VA-ECMO support

    From randomisation until VA-ECMO weanning assessed up to 28 days

  • Changes in vosoactive index score levels during VA-ECMO support

    From randomisation until VA-ECMO weanning assessed up to 28 days

  • +18 more secondary outcomes

Study Arms (2)

Individulised transfusion strategy group

EXPERIMENTAL

Patients will recieve red blood cells transfusion in case of a drop of ScVO2 \<65% after an assessment for the optimisation of SaO2 normalisation (SaO2\>94%), volume optimisation, ECMO output increase, Fever (body temperature 38°3 C°), Anxiety and Pain

Drug: Packed Red Blood Cells (PRBCs)

Conventionnal transfusion strategy group

ACTIVE COMPARATOR

Transfusion will be performed in case of a hemoglobin drop \<9 g/dL

Drug: Packed Red Blood Cells (PRBCs)

Interventions

Packed Red Blood Cells (PRBCs)DRUG

Patient will recieve PRBCs transfusion only in case of ScVO2 level\<65% after assessment of patient for optimisation of SaO2 targeting 100%, volume status, ECMO flow (increase to 20% in relevant), pain, anxiety and fever (body temperature \>38°3). In both groups transfusion may be performed in case massive bleeding according to local protocols, STEMI, Hyperlactatemia \>4 that can be related to oxygen demand and supply DO2/VO2 ratio impairement, in all groups, transfusion should be performed in case of hemolobin level \<7g/dL or worsening of neurological condition (Increase in Neurological SOFA component of 1 and more) related to DO2/VO2 impairement.

Also known as: ScVO2 assesment to guide transfusion
Conventionnal transfusion strategy groupIndividulised transfusion strategy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age of 18 and older,
  • supported by peripheral VA-ECMO
  • for cardiogenic shock
  • Life expentency \>90 days
  • Central venous line available ScVO2 measurement

You may not qualify if:

  • Pregnancy,
  • Lack of health insurance,
  • Opposition to blood transfusion,
  • Known congenital hemoglobin disease or disorder,
  • Metabolic alcaloosis with pH\>7.8,
  • eCPR,
  • Legally incapacitated adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Anesthésie-Réanimation CCV Hôpital Cardiologique Centre Hospitalier et Universitaire de Lille

Lille, NORD, 59000, France

RECRUITING

Related Publications (17)

  • Mazer CD, Whitlock RP, Fergusson DA, Hall J, Belley-Cote E, Connolly K, Khanykin B, Gregory AJ, de Medicis E, McGuinness S, Royse A, Carrier FM, Young PJ, Villar JC, Grocott HP, Seeberger MD, Fremes S, Lellouche F, Syed S, Byrne K, Bagshaw SM, Hwang NC, Mehta C, Painter TW, Royse C, Verma S, Hare GMT, Cohen A, Thorpe KE, Juni P, Shehata N; TRICS Investigators and Perioperative Anesthesia Clinical Trials Group. Restrictive or Liberal Red-Cell Transfusion for Cardiac Surgery. N Engl J Med. 2017 Nov 30;377(22):2133-2144. doi: 10.1056/NEJMoa1711818. Epub 2017 Nov 12.

    PMID: 29130845BACKGROUND

  • Fischer MO, Guinot PG, Debroczi S, Huette P, Beyls C, Babatasi G, Bafi K, Guilbart M, Caus T, Lorne E, Dupont H, Hanouz JL, Diouf M, Abou-Arab O. Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial. Br J Anaesth. 2022 Jan;128(1):37-44. doi: 10.1016/j.bja.2021.09.037. Epub 2021 Nov 30.

    PMID: 34862002BACKGROUND

  • Vallet B, Robin E, Lebuffe G. Venous oxygen saturation as a physiologic transfusion trigger. Crit Care. 2010;14(2):213. doi: 10.1186/cc8854. Epub 2010 Mar 9.

    PMID: 20236457RESULT

  • Aubron C, Cheng AC, Pilcher D, Leong T, Magrin G, Cooper DJ, Scheinkestel C, Pellegrino V. Factors associated with outcomes of patients on extracorporeal membrane oxygenation support: a 5-year cohort study. Crit Care. 2013 Apr 18;17(2):R73. doi: 10.1186/cc12681.

    PMID: 23594433RESULT

  • Mazzeffi M, Greenwood J, Tanaka K, Menaker J, Rector R, Herr D, Kon Z, Lee J, Griffith B, Rajagopal K, Pham S. Bleeding, Transfusion, and Mortality on Extracorporeal Life Support: ECLS Working Group on Thrombosis and Hemostasis. Ann Thorac Surg. 2016 Feb;101(2):682-9. doi: 10.1016/j.athoracsur.2015.07.046. Epub 2015 Oct 9.

    PMID: 26443879RESULT

  • Holst LB. Benefits and harms of red blood cell transfusions in patients with septic shock in the intensive care unit. Dan Med J. 2016 Feb;63(2):B5209.

    PMID: 26836806RESULT

  • Rohde JM, Dimcheff DE, Blumberg N, Saint S, Langa KM, Kuhn L, Hickner A, Rogers MA. Health care-associated infection after red blood cell transfusion: a systematic review and meta-analysis. JAMA. 2014 Apr 2;311(13):1317-26. doi: 10.1001/jama.2014.2726.

    PMID: 24691607RESULT

  • Leffell MS, Kim D, Vega RM, Zachary AA, Petersen J, Hart JM, Rossert J, Bradbury BD. Red blood cell transfusions and the risk of allosensitization in patients awaiting primary kidney transplantation. Transplantation. 2014 Mar 15;97(5):525-33. doi: 10.1097/01.tp.0000437435.19980.8f.

    PMID: 24300013RESULT

  • Vlaar AP, Hofstra JJ, Determann RM, Veelo DP, Paulus F, Kulik W, Korevaar J, de Mol BA, Koopman MM, Porcelijn L, Binnekade JM, Vroom MB, Schultz MJ, Juffermans NP. The incidence, risk factors, and outcome of transfusion-related acute lung injury in a cohort of cardiac surgery patients: a prospective nested case-control study. Blood. 2011 Apr 21;117(16):4218-25. doi: 10.1182/blood-2010-10-313973. Epub 2011 Feb 16.

    PMID: 21325598RESULT

  • Lorusso R, Gelsomino S, Parise O, Mendiratta P, Prodhan P, Rycus P, MacLaren G, Brogan TV, Chen YS, Maessen J, Hou X, Thiagarajan RR. Venoarterial Extracorporeal Membrane Oxygenation for Refractory Cardiogenic Shock in Elderly Patients: Trends in Application and Outcome From the Extracorporeal Life Support Organization (ELSO) Registry. Ann Thorac Surg. 2017 Jul;104(1):62-69. doi: 10.1016/j.athoracsur.2016.10.023. Epub 2017 Jan 26.

    PMID: 28131429RESULT

  • Kim HS, Park S. Blood Transfusion Strategies in Patients Undergoing Extracorporeal Membrane Oxygenation. Korean J Crit Care Med. 2017 Feb;32(1):22-28. doi: 10.4266/kjccm.2016.00983. Epub 2017 Feb 28.

    PMID: 31723612RESULT

  • Hebert PC, Wells G, Blajchman MA, Marshall J, Martin C, Pagliarello G, Tweeddale M, Schweitzer I, Yetisir E. A multicenter, randomized, controlled clinical trial of transfusion requirements in critical care. Transfusion Requirements in Critical Care Investigators, Canadian Critical Care Trials Group. N Engl J Med. 1999 Feb 11;340(6):409-17. doi: 10.1056/NEJM199902113400601.

    PMID: 9971864RESULT

  • Holst LB, Petersen MW, Haase N, Perner A, Wetterslev J. Restrictive versus liberal transfusion strategy for red blood cell transfusion: systematic review of randomised trials with meta-analysis and trial sequential analysis. BMJ. 2015 Mar 24;350:h1354. doi: 10.1136/bmj.h1354.

    PMID: 25805204RESULT

  • Mueller MM, Van Remoortel H, Meybohm P, Aranko K, Aubron C, Burger R, Carson JL, Cichutek K, De Buck E, Devine D, Fergusson D, Follea G, French C, Frey KP, Gammon R, Levy JH, Murphy MF, Ozier Y, Pavenski K, So-Osman C, Tiberghien P, Volmink J, Waters JH, Wood EM, Seifried E; ICC PBM Frankfurt 2018 Group. Patient Blood Management: Recommendations From the 2018 Frankfurt Consensus Conference. JAMA. 2019 Mar 12;321(10):983-997. doi: 10.1001/jama.2019.0554.

    PMID: 30860564RESULT

  • Guimbretiere G, Anselmi A, Roisne A, Lelong B, Corbineau H, Langanay T, Flecher E, Verhoye JP. Prognostic impact of blood product transfusion in VA and VV ECMO. Perfusion. 2019 Apr;34(3):246-253. doi: 10.1177/0267659118814690. Epub 2018 Nov 16.

    PMID: 30444173RESULT

  • Mazzeffi MA, Tanaka K, Roberts A, Rector R, Menaker J, Kon Z, Deatrick KB, Kaczorowski D, Griffith B, Herr D. Bleeding, Thrombosis, and Transfusion With Two Heparin Anticoagulation Protocols in Venoarterial ECMO Patients. J Cardiothorac Vasc Anesth. 2019 May;33(5):1216-1220. doi: 10.1053/j.jvca.2018.07.045. Epub 2018 Aug 3.

    PMID: 30181084RESULT

  • Zeroual N, Blin C, Saour M, David H, Aouinti S, Picot MC, Colson PH, Gaudard P. Restrictive Transfusion Strategy after Cardiac Surgery. Anesthesiology. 2021 Mar 1;134(3):370-380. doi: 10.1097/ALN.0000000000003682.

    PMID: 33475735RESULT

MeSH Terms

Conditions

Shock, CardiogenicAnemia

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisShockHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Mouhamed MOUSSA, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mouhamed MOUSSA, MD

CONTACT

0320445962mouhamed.moussa@chru-lille.fr

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Patients and datamanagement responsible for statistical analysis will be blinded of the patient allocation group until the study completion
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2022

First Posted

January 26, 2023

Study Start

September 18, 2023

Primary Completion

September 18, 2025

Study Completion

December 18, 2025

Last Updated

April 4, 2024

Record last verified: 2024-01

Locations

FR(1)