Prospective single blinded randomized controlled study comparing the efficacy of
epsilon-aminocaproic acid and tranexamic acid in pediatric patients undergoing
elective idiopathic scoliosis surgery

Background and Goal of Study: Epsilon-aminocaproic acid (EACA) and tranexamic acid
(TXA) are routinely used to prevent significant blood loss during multilevel pediatric
scoliosis surgeries. Efficacy of these anti-fibrinolytic drugs was demonstrated in cardiac,
total joint arthroplasty and in adult spine surgeries. To date very few studies have compared
the efficacy of these drugs in multilevel pediatric scoliosis surgeries. Purpose of this study
was to compare the efficacy of EACA and TXA in reducing intraoperative blood loss, postoperative
drain output and blood transfusion requirements. 

Materials and methods: This is a single center, prospective, single blinded, randomized
controlled pilot study comparing the efficacy of TXA and EACA used intra-operatively in
pediatric patients undergoing multilevel idiopathic scoliosis corrective surgery. After
obtaining IRB approval, idiopathic scoliosis patients undergoing corrective surgery were
randomly assigned to one of the two groups - TXA or EACA. The following parameters were
analyzed: intraoperative estimated blood loss (EBL), perioperative blood transfusion
requirements, surgical drain output on post operative day (POD)-1, POD-2, POD-3 and total
72 hr drain output.

Results and discussion: Forty six patients were randomly assigned to receive TXA (n=23)
and EACA (n=23). Groups were similar at baseline with regards to weight, starting
hematocrit level and gender distribution (Table 1). Age and number of spinal fusion levels
were different in the two groups. The median (25th and 75th percentile) EBL in TXA and
EACA group were 600 (400-800) and 600 (450-800) respectively, p value 0.580. The
median 72 hours drain output in the TXA and EACA group were 303.5 (186.5-553) and 330
(165-513) respectively, p value 0.991. Additionally there were no differences in the blood
transfusion requirements between the two groups.

Conclusion: TXA and EACA showed no difference in EBL, 72 hour drain output and blood
transfusion requirements in patients undergoing idiopathic scoliosis repair. The endpoints
analyzed did not demonstrate superiority of one drug over the other. Limitations of the study
are single center, small sample size; anesthesiologist was not blinded to the treatment and
occurrence of baseline differences in the two groups.

Prospective single blinded randomized controlled study comparing the efficacy of epsilon-aminocaproic acid and tranexamic acid in pediatric patients undergoing elective idiopathic scoliosis surgery