Impact of Blood Storage Duration on Physiologic Measures

Study Overview
=================
Brief Summary
-----------------
This study is an ancillary (add-on) study to the clinical trial entitled Red Cell Storage Duration Study (RECESS), which has clinicaltrials.gov identifier NCT00991341. The RECESS study randomizes cardiac surgery patients to receive either red blood cell units stored for no more than 10 days, or red blood cell units stored for at least 21 days, if they need any red blood cell transfusions during their hospital stay for the surgery. This ancillary study is entitled Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP). The hypothesis of the RECAP study is that there will be differences between the two randomized treatment groups in how much the following measurements change, from shortly before a red blood cell transfusion to shortly after a red blood cell transfusion, and from before surgery to 24 hours after surgery: Oxygen saturation in the hand Oxygen saturation in the brain Blood flow in the small blood vessels under the tongue. The RECAP study will also investigate whether changes in the measurements listed above are associated with clinical outcomes, including The Multi-Organ Dysfunction Score Death from any cause Major cardiac events Major pulmonary events

Official Title
-----------------
Impact of Blood Storage Duration on Physiologic Measures: RECESS Ancillary Physiologic Study (RECAP)

Conditions
-----------------
Cardiac Surgery, Erythrocyte Transfusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible and randomized in the RECESS study (NCT00991341) At least 18 years old Willing to comply with protocol and provide written informed consent for both RECESS and RECAP Scheduled to undergo coronary artery bypass (CABG), valve, or combined CABG plus valve surgery Exclusion Criteria: Prior randomization into the RECESS or RECAP studies Undergoing off-pump cardiac surgery Undergoing a significant concomitant surgical procedure Known sickle cell disease Participation in a clinical trial (except observational studies or RECESS) within the previous 30 days Received any investigational product within prior 30 days Not able to be randomized in RECESS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shorter-storage red blood cell units<br>Red blood cell units stored <= 10 days | |
| Longer-storage red blood cell units<br>Red blood cell units stored >= 21 days | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in thenar oxygenation saturation |  | From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in downslope of thenar oxygen saturation |  | From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. | 
| Change in upslope of thenar oxygen saturation |  | From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. | 
| Change in cerebral oxygenation |  | From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. | 
| Change in microvascular mean flow index |  | From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. | 
| Change in percent perfused vessels |  | From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. | 
| Change in capillary density index |  | From a measurement taken within 2 hours prior to the index transfusion, to a measurement taken within 2 hours following the index transfusion. | 
| Change in thenar oxygen saturation |  | From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery | 
| Change in downslope of thenar oxygen saturation |  | From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery | 
| Change in upslope of thenar oxygen saturation |  | From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery | 
| Change in cerebral oxygenation |  | From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery | 
| Change in microvascular mean flow index |  | From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery | 
| Change in percent perfused vessels |  | From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery | 
| Change in capillary density index |  | From a measurement taken within 6 hours prior to surgery, to a measurement taken 20-28 hours after surgery | 
| Change in multi-organ dysfunction score |  | From pre-surgery baseline to post-operative Day 7, hospital discharge, or death, whichever occurs first | 
| All-cause mortality |  | Through post-operative Day 28 | 
| Composite of major cardiac events |  | Through post-operative Day 7, hospital discharge, or death, whichever occurs first | 
| Composite of major pulmonary events |  | Through post-operative Day 7, hospital discharge, or death, whichever occurs first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Surgery, Red Blood Cell, Transfusion, Oxygen Saturation, Microvascular Flow