Clinical trial NCT03261583: Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery
Official title: Impact of Preoperative Martial Deficiency on the Level of Blood Transfusion in Programmed Cardiac Surgery (CARMATS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thoracic Surgery
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-08-25
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients programmed for cardiac surgery

Brief summary: Observational study.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of patients with iron deficiency
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Brest University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
Study officials:
affiliation: CHU Rennes
name: Baptiste Gaudriot
role: PRINCIPAL_INVESTIGATOR
References: