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

NCT00861822 | Completed Phase 1 DMC

• 1 other identifier: 08-1083-B
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Injury

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• (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

Study Arms (2)

RBC

ACTIVE COMPARATOR

Advance RBC transfusion' (ART) group

Other: Advanced red blood cell transfusion

Standard Care

OTHER

Standard-of-care RBC transfusion (SRT) group

Other: Advanced red blood cell transfusion

Interventions

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

RBC; Standard Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Anemia; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Keyvan Karkouti, MD

  Toronto General Hospital, Toronto, Ontario,Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: July 1, 2011
• Last Updated: February 25, 2013

Record last verified: 2013-02

Locations

CA (1)