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

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.

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Key information

Conditions

Kidney Injury Acute Kidney Injury Anemia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

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

Treatment and study plan

Advanced red blood cell transfusion

Other

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

Primary outcomes

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

Secondary outcomes

(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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Mar 13, 2009
Registry last updated: Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed