Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HL101382 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
The RECAP study will also investigate whether changes in the measurements listed above are associated with clinical outcomes, including
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shorter-storage red blood cell units | Red blood cell units stored <= 10 days | ||
| Longer-storage red blood cell units | Red blood cell units stored >= 21 days |
Not provided
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Cardiac surgery patients enrolled in the RECESS study (NCT00991341) at selected hospitals
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Elliott Bennett-Guerrero, MD | Duke University | Principal Investigator |
| Christopher Stowell, MD, PHD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| Brigham and Womens Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28027790 | Result | Stowell CP, Whitman G, Granger S, Gomez H, Assmann SF, Massey MJ, Shapiro NI, Steiner ME, Bennett-Guerrero E. The impact of red blood cell storage duration on tissue oxygenation in cardiac surgery. J Thorac Cardiovasc Surg. 2017 Mar;153(3):610-619.e2. doi: 10.1016/j.jtcvs.2016.11.029. Epub 2016 Nov 19. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |