A Phase 1 interventional study of Advanced red blood cell transfusion in Kidney Injury, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-25.
Sponsored by University Health Network, Toronto · Phase 1, Interventional, and Prevention
One of the major complications of heart surgery is kidney injury, which occurs in up to 30% of patients and is associated with poor outcomes including death. We have found that patients whose hemoglobin concentration before surgery is lower than normal (i.e., are anemic) are at particularly high risk for this complication, likely because their hemoglobin concentration drops to very low levels during surgery, which reduces delivery of oxygen to the kidneys, increases blood loss, and necessitates blood transfusions. We and others have shown that these events are individually harmful to the kidneys, and can lead to kidney injury. We believe that we can prevent these events from occurring, and as a result reduce the risk of kidney injury, if we transfuse anemic patients at least 1 day before surgery rather than during surgery.
In anemic patients undergoing cardiac surgery, prophylactic transfusion of red blood cells (RBCs) before surgery will reduce the risk of acute kidney injury (AKI) after surgery by mitigating three inter-related risk factors for AKI.
University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Advance RBC transfusion' (ART) group
Other: Advanced red blood cell transfusion
Standard-of-care RBC transfusion (SRT) group
Other: Advanced red blood cell transfusion
Sixty anemic (Hg 100-120 g/L) adult patients undergoing cardiac surgery with CPB will be randomized to the 'advance RBC transfusion' (ART) group or the standard-of-care RBC transfusion' (SRT) group (1:1 ratio). In the ART group, subjects will receive 1-2 units of stored RBCs 1-2 days before surgery to reach a target Hb of 130-140 g/L. Each unit of blood will be transfused over 2 hours under medical supervision, with appropriate monitoring and management of fluid status to ensure patients are not over-hydrate
Effects on perioperative (within 72 hours of termination of CPB) anemia will be measured by: incidence of profound perioperative anemia (Hb < 70 g/L) and by nadir perioperative Hb concentration.
Time frame: preoperatively, intraoperatively, postoperatively, daily until discharge
(Primary)Effects on periop RBC transfusion rates measured by: incidence and amount of periop RBC transfusions. Effects on periop coagulation measured by: incidence and amount of coagulation product transfusions and incidence of surgical re-exploration.
Time frame: preoperatively, intraoperatively, postoperatively, daily until discharge
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto