NCT04141631

Brief Summary

Preoperative anemia, bleeding and transfusions have been recognized as a "Deadly triad" in cardiac surgery associated with an increased morbidity,mortality, and costs related. Thus strategies to reduce unnecessary RBC transfusions and to optimize preoperative anemia must be developed .The study evaluate an individual blood conservation strategy based on patient blood management bundles in cardiac surgery patients: optimisation perioperative hemoglobin level by erythropoietin and ferric carboxymaltose (Ferinject) associated with the use of ScV02 to guide perioperative erythrocyte transfusion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

October 4, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2022

Completed
Last Updated

October 27, 2022

Status Verified

September 1, 2022

Enrollment Period

2.3 years

First QC Date

October 4, 2019

Last Update Submit

October 25, 2022

Conditions

Cardiac SurgeryTransfusionPerioperative Anemia

Keywords

Perioperative ErythropoietinPerioperative IronScVO2Patient blood ManagementBlood Transfusion

Outcome Measures

Primary Outcomes (1)

  • Transfusion incidence at hospital discharge

    Number of patients transfused of blood units

    up to Day 28

Secondary Outcomes (8)

  • ICU transfusion incidence

    at ICU discharge or up to Day 28

  • total of blood units transfused

    up to day 28

  • Hemoglobin level at surgery discharge and Hemoglobin level at 1 month after discharge from hospital

    at surgery discharge (or at Day 28) and at 1 month after discharge from hospital

  • The total duration of mechanical ventilation

    at ICU discharge or up to Day 28

  • length of stay in ICU

    up to day 28

  • +3 more secondary outcomes

Study Arms (2)

STOP Group

EXPERIMENTAL

EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if * Hb \< 13g/dL the day before surgery * Hb ≥ 7g/dL AND ScvO2 \> 65% in postoperative ICU stay Postoperative Transfusion will be guided by ScvO2 values : if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb \< 7g/dL independently of ScVO2 value

Drug: EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)

Control Group

NO INTERVENTION

Only postoperative anemia will be managed: * RBC transfusion will be performed if Hb ≤ 8 g/dL (2017 EACTS/EACTA guidelines) * Iron sucrose administration if Hb \> 8g/dL : 2 injections of 200 mg according to Height (+/- 70 Kg) in 250 mL of saline solution 0.9% over 1h30 into 48 h intervals without exceeding a total dose of 15mg/kg.

Interventions

EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)DRUG

EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if * Hb \< 13g/dL the day before surgery * Hb ≥ 7g/dL AND ScvO2 \> 65% in postoperative ICU stay Postoperative Transfusion will be guided by ScvO2 values : if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb \< 7g/dL independently of ScVO2 value

STOP Group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled Cardiac surgery for more than 24 hours
  • High risk of perioperative transfusion defined by a TRUST Score ≥ 3
  • Veno-Venous catheter in Superior vena cava territory
  • Patient Affiliate or beneficiary of social security
  • Collection on free, informed and written consent

You may not qualify if:

  • EPO and FCM contraindication
  • Non controlled Infectious endocarditis defined by ESC guidelines 2015
  • Patients including in an other research
  • Patients whose physical and/or psychological health is severely impaired and who, according to the investigator, may affect the participant's compliance with the study.
  • Patients deprived from his rights (guardianship or tutelage measure)
  • Patients who refuses to sign the consent
  • pregnant or lactating woman

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DEpartement d'anesthésie et réanimation D - Arnaud de Villeneuve

Montpellier, 34295, France

Location

Related Publications (5)

  • Ranucci M, Baryshnikova E, Castelvecchio S, Pelissero G; Surgical and Clinical Outcome Research (SCORE) Group. Major bleeding, transfusions, and anemia: the deadly triad of cardiac surgery. Ann Thorac Surg. 2013 Aug;96(2):478-85. doi: 10.1016/j.athoracsur.2013.03.015. Epub 2013 May 11.

    PMID: 23673069BACKGROUND

  • Plicht B, Lind A, Erbel R. [Infective endocarditis : New ESC guidelines 2015]. Internist (Berl). 2016 Jul;57(7):675-90. doi: 10.1007/s00108-016-0086-y. German.

    PMID: 27307162BACKGROUND

  • Alghamdi AA, Davis A, Brister S, Corey P, Logan A. Development and validation of Transfusion Risk Understanding Scoring Tool (TRUST) to stratify cardiac surgery patients according to their blood transfusion needs. Transfusion. 2006 Jul;46(7):1120-9. doi: 10.1111/j.1537-2995.2006.00860.x.

    PMID: 16836558BACKGROUND

  • Task Force on Patient Blood Management for Adult Cardiac Surgery of the European Association for Cardio-Thoracic Surgery (EACTS) and the European Association of Cardiothoracic Anaesthesiology (EACTA); Boer C, Meesters MI, Milojevic M, Benedetto U, Bolliger D, von Heymann C, Jeppsson A, Koster A, Osnabrugge RL, Ranucci M, Ravn HB, Vonk ABA, Wahba A, Pagano D. 2017 EACTS/EACTA Guidelines on patient blood management for adult cardiac surgery. J Cardiothorac Vasc Anesth. 2018 Feb;32(1):88-120. doi: 10.1053/j.jvca.2017.06.026. Epub 2017 Sep 30. No abstract available.

    PMID: 29029990BACKGROUND

  • Saour M, Blin C, Zeroual N, Mourad M, Amico M, Gaudard P, Picot MC, Colson PH. Impact of a bundle of care (intravenous iron, erythropoietin and transfusion metabolic adjustment) on post-operative transfusion incidence in cardiac surgery: a single-centre, randomised, open-label, parallel-group controlled pilot trial. Lancet Reg Health Eur. 2024 Jun 24;43:100966. doi: 10.1016/j.lanepe.2024.100966. eCollection 2024 Aug.

    PMID: 39022429DERIVED

MeSH Terms

Interventions

ferric carboxymaltoseFosfomycinSaline Solution

Intervention Hierarchy (Ancestors)

OrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2019

First Posted

October 28, 2019

Study Start

January 13, 2020

Primary Completion

May 10, 2022

Study Completion

June 15, 2022

Last Updated

October 27, 2022

Record last verified: 2022-09

Locations

FR(1)