Clinical trial NCT01915654: Impact of RBC Transfusion Less Than 14 Days on Morbidity and Mortality in Cardiac Surgical Patients
Official title: Impact de la Transfusion de Culots Globulaires de Moins de 14 Jours Sur la Morbi-mortalité Chez Des Patients en Chirurgie Cardiaque
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Postoperative; Dysfunction Following Cardiac Surgery
Transfusion Related Complication
Keywords: Cardiac surgery
Transfusion
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2013-08-05
Enrollment: 459
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study involves patients operated in the cardiothoracic and ardio-vascular surgery department of Besançon University Hospital between December 2008 and May 2009 (study population) or from December 2007 to May 2008 and from December 2009 to May 2010 (reference population).

Brief summary: The purpose of the transfusion of packed red blood cell is to overcome acute or chronic anemia cause tissue hypoxia. It increases hemoglobin concentration and consequently increase oxygen delivery to peripheral tissues. The perioperative period of major surgery is a field particularly favorable to the development of tissue hypoxia, which is associated with increased mortality and postoperative morbidity. Optimization of oxygen transport to tissues at the preoperative period is accompanied by a significant reduction of these major complications.

Clinical complications (infectious or otherwise) related to transfusion of caps Red Blood cells Caps (RBC)are well known. Many studies seem to evidence the potentially deleterious effect of transfusion, especially in patients with poor condition, related to storage time. Indeed, during storage, impaired blood-related storage is created. It is metabolic, biochemical and molecular levels. Many studies, carried out in particular in cardiac surgery where patients are suitable for transfusion RBC, have focused on the effect of transfusions on consumption and the transport of oxygen to demonstrate the impact of conservation lesions on their role in vivo. In particular, a single-center retrospective American study showed reduction of postoperative complications in patients who received RBC under 14 days.

However one of the confounding factors present is that all transfused RBCs are not leukoreduced (unlike the French transfusion policy). In addition, the greater part of the clinical studies are controversial. That is why we aim to assess, through a retrospective study of data, the impact of transfusion of red red blood cells within 14 days of post-operative morbidity and mortality, compared to the usual transfusion practice in cardiac surgery patients.


Eligibility criteria: Inclusion Criteria:

* Patients male or female over the age of 18 years
* Patients able to understand the benefits and risks of testing
* For the study population: patients who underwent cardiac surgery (all surgery combined) scheduled or emergency December 2008 to May 2009, having been transfused intraoperatively and until the seventh postoperative day .
* For the reference population: patients who have undergone elective or emergency cardiac surgery from December 2007 to May 2008 and from December 2009 to May 2010, having been transfused intraoperatively and until the seventh postoperative day.

Exclusion Criteria:

* Inability to understand the advantages and disadvantages of the study, psychiatric disorders judged by the investigator to be incompatible with the inclusion in the study.
* Patients who have expressed opposition to his participation in the study.
* For the study population: patients were transfused within seven days before the start of the observation period.
* For the study population: patients with transfusion of red blood cell more than 14 days
* For the reference population: patients were transfused within seven days before surgery.

Primary outcomes:
measure: death / acute renal failure / operating / stroke / postoperative ischemia post infection
timeFrame: in-beyond the 48th hour of the transfusion
Secondary outcomes:
measure: Mortality / average length of stay in intensive care / resuscitation (> 48 hours) / the average length of stay in cardiac surgery
timeFrame: 30 days
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: CHRU de Besançon
name: Guillaume Flicoteaux
role: PRINCIPAL_INVESTIGATOR
References: