SUMMARY
AMINOCAPROIC ACID INJECTION, USP
Aminocaproic Acid Injection, USP is 6-aminohexanoic acid, which acts as an inhibitor of fibrinolysis.
Aminocaproic Acid (aminocaproic acid) is indicated for the following:
Aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. In life-threatening situations, fresh whole blood transfusions, fibrinogen infusions, and other emergency measures may be required.
Fibrinolytic bleeding may frequently be associated with surgical complications following heart surgery (with or without cardiac bypass procedures) and portacaval shunt; hematological disorders such as aplastic anemia; abruptio placentae; hepatic cirrhosis; neoplastic disease such as carcinoma of the prostate, lung, stomach, and cervix.
Urinary fibrinolysis, usually a normal physiological phenomenon, may frequently be associated with life-threatening complications following severe trauma, anoxia, and shock. Symptomatic of such complications is surgical hematuria (following prostatectomy and nephrectomy) or nonsurgical hematuria (accompanying polycystic or neoplastic diseases of the genitourinary system). (See WARNINGS.)
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NEWS HIGHLIGHTS
Published Studies Related to Aminocaproic Acid
Epsilon-aminocaproic acid influence in postoperative [corrected] bleeding and hemotransfusion [corrected] in mitral valve surgery. [2010.10] INTRODUCTION: The epsilon aminocaproic acid is an antifibrinolytic used in cardiovascular surgery to inhibit the fibrinolysis and to reduce the bleeding after CPB. [corrected] OBJECTIVE: To analyze the influence of the using of epsilon aminocaproic acid in the bleeding and in red-cell transfusion requirement in the first twenty-four hours postoperative of mitral valve surgery... CONCLUSION: The epsilon aminocaproic acid was able to reduce the bleeding volume and the red-cell transfusion requirement in the immediate postoperative of patients submitted to mitral valve surgery.
A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery. [2010.04.06] BACKGROUND: Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed... Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes.
A prospective, randomized, double-blinded single-site control study comparing
blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid
(EACA) for corrective spinal surgery. [2010] BACKGROUND: Multilevel spinal fusion surgery has typically been associated with
significant blood loss. To limit both the need for transfusions and
co-morbidities associated with blood loss, the use of anti-fibrinolytic agents
has been proposed... Based on current
literature and the mechanism by which the medications act, we hypothesize that
TXA will be more effective at reducing blood loss than EACA or placebo and result
in improved patient outcomes.
Effect of epsilon aminocaproic acid on red-cell transfusion requirements in major spinal surgery. [2009.09.01] STUDY DESIGN.: Randomized, placebo-controlled trial.Larger studies are needed to evaluate the relationship between EACA and total RBC requirements.
The effect of epsilon-aminocaproic acid and aprotinin on fibrinolysis and blood loss in patients undergoing primary, isolated coronary artery bypass surgery: a randomized, double-blind, placebo-controlled, noninferiority trial. [2009.07] BACKGROUND: Until recently, aprotinin was the only antifibrinolytic drug with a licensed indication in cardiac surgery in the United States. The most popular alternative, epsilon-aminocaproic acid (EACA), has not been adequately compared with aprotinin. We undertook this study to test the hypothesis that EACA, when dosed appropriately, is not inferior to aprotinin at reducing fibrinolysis and blood loss... CONCLUSIONS: When dosed in a pharmacologically guided manner, EACA is not inferior to aprotinin in reducing fibrinolysis and blood loss in patients undergoing primary, isolated coronary artery bypass surgery.
Clinical Trials Related to Aminocaproic Acid
Amicar Pharmacokinetics of Children Having Craniofacial Surgery [Recruiting]
Craniofacial reconstruction surgery involves a surgical approach to the craniofacial region
to repair cranial vault and facial deformities. The surgery is extensive, often requiring
wide scalp dissections and multiple osteotomies and has been associated with significant
morbidity. Some of the most severe and commonly seen problems are associated with the rate
and extent of blood loss.
Efforts to minimize surgical bleeding may translate to reduced transfusion requirements and
a lessening of associated risks Epsilon-aminocaproic acid (EACA), an inhibitor of
fibrinolysis, reduces transfusion requirements in children undergoing procedures on
cardiopulmonary bypass (CPB), as well as in older children undergoing spinal surgery for
scoliosis (1-6).
Before controlled studies to assess efficacy of EACA in a craniofacial surgical population
can be done, appropriate pharmacokinetic (PK) data are needed to determine the optimal
dosing strategy. PK data exist for EACA in children undergoing operations on CPB and
hypothermia.
The aim of this study is to determine the pharmacokinetics of EACA in infants and children
undergoing craniofacial reconstruction procedures.
Effects of Aminocaproic Acid (ACA) on Rosacea-specific Inflammation [Recruiting]
The purpose of this study is to determine the effect of topical aminocaproic acid on the
immune system by assessing the levels of antimicrobial peptides in the skin of patients with
rosacea. It is hypothesized that aminocaproic acid applied topically will alter the body's
immune system in patients with rosacea by inhibiting activation of antimicrobial peptides.
Tranexamic Acid (TXA) Versus Epsilon Aminocaproic Acid (EACA) Versus Placebo for Spine Surgery [Recruiting]
Tranexamic acid (TXA) and epsilon aminocaproic acid (EACA) have been reported to reduce
blood loss in the cardiac surgery literature but they have not been reported in use
head-to-head in the orthopedic surgery literature. In a randomized, double-blind,
prospective study we believe that TXA will be more effective than both EACA and placebo at
reducing blood loss for corrective spinal surgery.
Comparison of Tranexamic to Epsilon Aminocaproic Acid: a Prospective Analysis of Blood Conservation in Cardiac Surgery [Recruiting]
We hypothesize that tranexamic acid administration will be associated with 25% improvement
in the volume of blood loss and red blood cell (RBC) administration, with no increase or a
decrease in perioperative complications
Epsilon Aminocaproic Acid (EACA) for the Reduction of Blood Loss in Total Hip Arthroplasty (THA) [Recruiting]
You are being asked to take part in this research study because you are scheduled to have
total hip replacement (arthroplasty) surgery. The goal of this study is to evaluate the
effectiveness of the drug, epsilon Aminocaproic Acid (EACA), in decreasing the need for
patients to receive blood after surgery. Currently, EACA is approved by the Federal Drug
Administration (FDA) to treat a patient who is bleeding. The investigators plan to use EACA
to prevent bleeding during and after surgery; use of this drug as a means of preventing
bleeding is not currently approved by the FDA.
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