Status:
COMPLETED
The Effect of Intravenous EACA on Blood Loss and Transfusion Requirements After Bilateral VRO
Lead Sponsor:
Hospital for Special Surgery, New York
Conditions:
E-Aminocaproic Acid
Bilateral Varus Rotational Osteotomy
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief 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 ...
Detailed Description
The participating anesthesiologists will not be blinded to study arms and hypotheses. Dr. Christopher Edmonds will be the head anesthesiologist for this study and will administer anesthetics to partic...
Eligibility Criteria
Inclusion
- Scheduled for bilateral varus rotational osteotomy (VRO) with or without associated soft tissue and osseous procedures
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 26 2020
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02257580
Start Date
April 1 2015
End Date
October 26 2020
Last Update
November 23 2022
Active Locations (1)
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1
Hospital for Special Surgery
New York, New York, United States, 10021