Advance Targeted Transfusion in Anemic Cardiac Surgical Patients for Kidney Protection: A Proof of Concept Pilot Study

Phase 1

Completed

• Conditions: Kidney Injury
• Interventions: Other: Advanced red blood cell transfusion

• Registration Number: NCT00861822
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-03-12
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Study Start: 2009-07
• Primary Completion: 2011-04
• Study Completion: 2011-07
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-22
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients undergoing non-emergent aortocoronary bypass (ACB) surgery, or valve surgery, combined ACB and valve, or aortic root repair requiring CPB with a preoperative Hb concentration between 100 and 120 g/L.

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Exclusion Criteria

• Any conditions that may limit the ability of patients to tolerate the intervention:
• Severe aortic or mitral valve stenosis
• History of congestive heart failure within 30 days of surgery or severe ventricular dysfunction (ejection fraction < 30%)
• Severe (> 60%) left main coronary artery stenosis or unstable angina within 30 days of surgery

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RBC	Advanced red blood cell transfusion	Advance RBC transfusion' (ART) group
Standard Care	Advanced red blood cell transfusion	Standard-of-care RBC transfusion (SRT) group

Primary Outcome Measures

Name	Time	Method
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.	preoperatively, intraoperatively, postoperatively, daily until discharge

Secondary Outcome Measures

Name	Time	Method
(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.	preoperatively, intraoperatively, postoperatively, daily until discharge

Trial Locations

Locations (1)

Toronto General Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada