Impact of RBC Transfusion Less Than 14 Days on Morbidity and Mortality in Cardiac Surgical Patients

Transfusion Related Complication Clinical Trial

— CGRCard  

Official title:

Impact de la Transfusion de Culots Globulaires de Moins de 14 Jours Sur la Morbi-mortalité Chez Des Patients en Chirurgie Cardiaque

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01915654
• Other study ID #: P/2013/194
• Status: Terminated
• Phase: N/A
• First received: August 2, 2013
• Last updated: July 21, 2016
• Start date: January 2013
• Est. completion date: December 2013

Study information

• Verified date: August 2013
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 459
• Est. completion date: December 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Postoperative; Dysfunction Following Cardiac Surgery
• Transfusion Related Complication

Intervention

Procedure:
• study population
Population of patients undergoing cardiac surgery between December 2008 and May 2009, with pellets transfused RBCs stored for less than 14 days

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Besançon	Besançon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death / acute renal failure / operating / stroke / postoperative ischemia post infection	The primary endpoint was the occurrence of death and / or acute renal failure and / or operating and / or stroke and / or postoperative ischemia post infection, in-beyond the 48th hour of the transfusion.	in-beyond the 48th hour of the transfusion	No
Secondary	Mortality / average length of stay in intensive care / resuscitation (> 48 hours) / the average length of stay in cardiac surgery	The secondary endpoints were mortality at 30 days, the average length of stay in intensive care / resuscitation (> 48 hours) and (> 15 days).	30 days	No