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

Sponsored by:	University Health Network, Toronto
Information provided by:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00861822

Purpose

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.

Condition	Intervention	Phase
Kidney Injury	Other: Advanced red blood cell transfusion	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Official Title:	Advance Targeted Transfusion in Anemic Cardiac Surgical Patients for Kidney Protection: A Proof of Concept Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Heart Surgery Surgery

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

(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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	60
Study Start Date:	March 2009
Estimated Study Completion Date:	May 2011
Estimated Primary Completion Date:	March 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
RBC: Active Comparator Advance RBC transfusion' (ART) 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
Standard Care 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

Arms

Assigned Interventions

RBC: Active Comparator

Advance RBC transfusion' (ART) 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

Standard Care

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861822

Contacts

Contact: Keyvan Karkouti, MD	416-340-4800 ext 8597	keyvan.karkouti@uhn.on.ca
Contact: Jo Carroll	416-34-4800 ext 3243	jo.carroll@uhn.on.ca

Locations

Canada, Ontario
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4

Sponsors and Collaborators

University Health Network, Toronto

Investigators

Principal Investigator:

Keyvan Karkouti, MD

Toronto General Hospital, Toronto, Ontario,Canada

More Information

No publications provided

Responsible Party:	Toronto General Hospital, University Health Network ( Keyvan Karkouti )
Study ID Numbers:	08-1083-B
Study First Received:	March 12, 2009
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00861822 History of Changes
Health Authority:	Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:

Anemia
Cardiac surgery
RBC transfusion
Acute Kidney Injury
Cardiac surgery with cardiopulmonary bypass

Study placed in the following topic categories:

Anemia

ClinicalTrials.gov processed this record on September 10, 2009