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

NCT ID: NCT03261583

Last Updated: 2018-09-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 444 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-11-14
• Study Completion Date: 2018-01-15

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.

Conditions

Thoracic Surgery

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Thoracic Surgery

Observational study. It is only a matter of collecting clinical data.

Thoracis Surgery - Common care

Intervention Type: OTHER

Observational study. It is only a matter of collecting clinical data.

Interventions

Thoracis Surgery - Common care

Observational study. It is only a matter of collecting clinical data.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rennes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baptiste Gaudriot

Role: PRINCIPAL_INVESTIGATOR

CHU Rennes

Locations

Brest University Hospital

Brest, , France

Rennes University Hospital

Rennes, , France

Countries

France

Other Identifiers

35RC16_3051_CARMATS

Identifier Type: -

Identifier Source: org_study_id