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Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery.

ABSTRACT: : Randomized, placebo-controlled trial.: To evaluate the efficacy of epsilon aminocaproic acid (EACA) to reduce the number of red-cell (RBC) transfusions in adult patients undergoing major spinal surgery.: Reconstructive spinal surgery is associated with significant blood loss. The number of studies evaluating the efficacy of EACA in adult patients undergoing spinal surgery remains scarce and limited.: EACA (100 mg/kg) or placebo was administered to 182 adult patients after the induction of anesthesia followed by an infusion that was continued for 8 hours after surgery. Primary end points included total allogeneic RBC transfusions through postoperative day 8 and postoperative allogeneic plus autologus RBC transfusions through postoperative day 8.: Mean total allogeneic RBC transfusions were not statistically different between the groups (5.9 units EACA vs. 6.9 units placebo; P = 0.17). Mean postoperative RBC transfusions in the EACA group was less (2.0 units vs. 2.8 units placebo; P = 0.03). There was no significantdifference in mean estimated intraoperative estimated-blood loss (2938 cc EACA vs. 3273 cc placebo; P = 0.32). Mean intensive care unit length of stay was decreased (EACA: 1.8 days vs. 2.8 days placebo; P = 0.04). The incidence of thromboembolic complications was similar (2.2% EACA vs. 6.6% placebo; P = 0.15).: The difference in total allogeneic RBC transfusions between the groups was not statistically significant. EACA was associated with a 30% (0.8 units) reduction in postoperative RBC transfusions and a 1-day reduction in ICU LOS, without an increased incidence of thromboembolic events. EACA may be considered for patients undergoing major spinal surgery. Larger studies are needed to evaluate the relationship between EACA and total RBC requirements.

SUBMITTER: Berenholtz SM

PROVIDER: S-EPMC2772136 | biostudies-literature | 2009 Sep

REPOSITORIES: biostudies-literature

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Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery.

Berenholtz Sean M SM Pham Julius Cuong JC Garrett-Mayer Elizabeth E Atchison Christine W CW Kostuik John P JP Cohen David B DB Nundy Shantanu S Dorman Todd T Ness Paul M PM Klag Michael J MJ Pronovost Peter J PJ Kebaish Khaled M KM

Spine 20090901 19

<h4>Study design</h4>: Randomized, placebo-controlled trial.<h4>Objective</h4>: To evaluate the efficacy of epsilon aminocaproic acid (EACA) to reduce the number of red-cell (RBC) transfusions in adult patients undergoing major spinal surgery.<h4>Summary of background data</h4>: Reconstructive spinal surgery is associated with significant blood loss. The number of studies evaluating the efficacy of EACA in adult patients undergoing spinal surgery remains scarce and limited.<h4>Methods</h4>: EACA ...[more]

PMID: 19730217

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Project description:Background:When safe to do so, avoiding blood transfusions in cardiac surgery can avoid the risk of transfusion-related infections and other complications while protecting a scarce resource and reducing costs. This protocol describes a kidney substudy of the Transfusion Requirements in Cardiac Surgery III (TRICS-III) trial, a multinational noninferiority randomized controlled trial to determine whether the risk of major clinical outcomes in patients undergoing planned cardiac surgery with cardiopulmonary bypass is no greater with a restrictive versus liberal approach to red blood cell transfusion. Objective:The objective of this substudy is to determine whether the risk of acute kidney injury is no greater with a restrictive versus liberal approach to red blood cell transfusion, and whether this holds true in patients with and without preexisting chronic kidney disease. Design and Setting:Multinational noninferiority randomized controlled trial conducted in 73 centers in 19 countries (2014-2017). Patients:Patients (~4800) undergoing planned cardiac surgery with cardiopulmonary bypass. Measurements:The primary outcome of this substudy is perioperative acute kidney injury, defined as an acute rise in serum creatinine from the preoperative value (obtained in the 30-day period before surgery), where an acute rise is defined as ?26.5 ?mol/L in the first 48 hours after surgery or ?50% in the first 7 days after surgery. Methods:We will report the absolute risk difference in acute kidney injury and the 95% confidence interval. We will repeat the primary analysis using alternative definitions of acute kidney injury, including staging definitions, and will examine effect modification by preexisting chronic kidney disease (defined as a preoperative estimated glomerular filtration rate [eGFR] <60 mL/min/1.73 m2). Limitations:It is not possible to blind patients or providers to the intervention; however, objective measures will be used to assess outcomes, and outcome assessors will be blinded to the intervention assignment. Results:Substudy results will be reported by the year 2018. Conclusions:This substudy will provide generalizable estimates of the risk of acute kidney injury of a restrictive versus liberal approach to red blood cell transfusion in the presence of anemia during cardiac surgery done with cardiopulmonary bypass. Trial Registration:www.clinicaltrials.gov; clinical trial registration number NCT 02042898.

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Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery.

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Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery.

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