The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO

• Status: Completed
• Trial end date: 2020-10-26
• Target enrollment: 0
• Participant gender: All

Summary

E-Aminocaproic acid (EACA) is an anti-fibrinolytic agent that is used to decrease blood loss and transfusion requirements after several orthopedic procedures. The aim of this prospective double-blind placebo-controlled randomized trial is to determine whether IV EACA reduces intra-operative calculated total blood loss in patients undergoing bilateral varus rotational osteotomy (VRO). This study will also investigate intraoperative cell saver utilization, transfusion of allogeneic blood, hospital length-of-stay (LOS), short term complications, and long-term outcomes.This study will provide Level I evidence and has the potential to improve outcomes in children undergoing this procedure.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Aminocaproic Acid

Criteria

Inclusion Criteria:

• Scheduled for bilateral varus rotational osteotomy (VRO) with or without associated soft tissue and osseous procedures

Exclusion Criteria:

• Preoperative use of an anticoagulant (Plavix, warfarin, lovenox, etc.)

• History of hypersensitivity to EACA

• History of thromboembolic event (e.g., PE or DVT)

• History of renal insufficiency or failure

• Congenital or acquired coagulopathy as evidence by INR >1.4 or PTT > 1.4 times normal, or Platelets <150,000/mm3 on preoperative laboratory testing

• Use of hormone replacement therapy or hormonal contraceptive agents within days prior to surgery

• Use of acetylsalicylic acid (ASA), antiplatelet agents within 7 days prior to surgery

• Pregnant

• Breastfeeding

• Not received neuraxial anesthesia