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Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)

17. september 2018 opdateret af: Rennes University Hospital

Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)

Observational study.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Blood transfusion is expensive, and has medical and safety consequences for patients who benefit from it. In cardiac surgery, the data concerning the level of perioperative transfusion are very heterogeneous from one center to another. In a large US cohort study of 798 cardiac surgery centers and 102,470 patients undergoing coronary artery bypass surgery, the rate of blood transfusion varies from 8 to 93% depending on the center. It would appear that the largest and most experienced centers have a blood transfusion rate of around 60%.

In addition to its beneficial role in reducing mortality induced by deep or poorly tolerated anemia, current data from the literature also raise morbidity and mortality related to blood transfusion. Murphy et al. Have shown, in an English cohort of cardiac surgery, that transfusion of CGR was correlated with the occurrence of postoperative infections and ischemic events, as well as early and late excess mortality. These effects appear as early as the first transfused red blood cell, which is confirmed by a prospective Brazilian study with a hazard ratio of death occurrence of 1.2 for each RBC transfused after cardiac surgery.

Preoperative anemia is found in 25% of patients in programmed cardiac surgery and its etiologies are varied. Iron deficiency appears to be at the forefront, especially in coronary patients for whom studies report up to 48% iron deficiency anemia. It may also be vitamin B12 deficiency or folate, chronic pathologies such as renal insufficiency, or any other common cause of anemia.

According to the latest European recommendations, iron deficiency should be defined as <100 ng / mL ferritin or <300 ng / mL ferritin combined with a transferrin saturation <20%.

In cardiac surgery, iron deficiency affects 37% of preoperative patients and is associated with more frequent preoperative and postoperative anemia. It is an independent risk factor for postoperative blood transfusion, even in the absence of preoperatively associated anemia It is currently recommended to seek iron deficiency preoperatively during the discovery of any microcytic anemia and to achieve iron substitution if found. And also to seek supplemental iron deficiency in all patients with cardiac insufficiency.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

444

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Brest, Frankrig, 29609
        • Brest University Hospital
      • Rennes, Frankrig, 35033
        • Rennes University Hospital

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

All adult patients programmed for cardiac surgery

Beskrivelse

Inclusion Criteria:

All adult patients programmed for cardiac surgery in the cardiothoracic surgery departments of Rennes, Poitiers, and Brest.

Exclusion Criteria:

  • Children <18 years;
  • Procedures for endovascular surgery;
  • Vascular surgery other than ascending aorta and lacrosse;
  • Non-cardiac thoracic surgery;
  • Persons of full age who are subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of their liberty.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Thoracic Surgery
Observational study. It is only a matter of collecting clinical data.
Observational study. It is only a matter of collecting clinical data.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Incidence of patients with iron deficiency
Tidsramme: Baseline
Baseline

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Baptiste Gaudriot, Chu Rennes

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

14. november 2016

Primær færdiggørelse (Faktiske)

15. januar 2018

Studieafslutning (Faktiske)

15. januar 2018

Datoer for studieregistrering

Først indsendt

23. august 2017

Først indsendt, der opfyldte QC-kriterier

23. august 2017

Først opslået (Faktiske)

25. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 35RC16_3051_CARMATS

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Thoraxkirurgi

3
Abonner