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

NCT00861822 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2013-02-25

No results posted yet for this study

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.

Conditions

  • Kidney Injury

Interventions

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

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Keyvan Karkouti, MD · Toronto General Hospital, Toronto, Ontario,Canada

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-07-31
Primary Completion
2011-04-30
Completion
2011-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861822 on ClinicalTrials.gov