Status:
WITHDRAWN
The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO
Lead Sponsor:
Boston Children's Hospital
Conditions:
Bleeding
Eligibility:
All Genders
13-35 years
Phase:
PHASE4
Brief Summary
In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during Periacetabular Osteotomy (PAO) surgery. TXA is approve...
Detailed Description
This prospective randomized placebo controlled double blind trial will enroll 80 adolescents and young adults undergoing elective peri-acetabular osteotomy (PAO). The primary aim is to determine if in...
Eligibility Criteria
Inclusion
- ASA 1-2
- Age 13-35 years
- Scheduled for primary unilateral PAO +/- arthroscopy
Exclusion
- Hematologic disorder, thrombocytopenia (Platelet count \<140,000/uL3)
- Major hepatic, renal, or vascular disorder
- Active Thromboembolic disorder
- Color vision defect
- TXA allergy
- Taking anticoagulants or antiplatelet drugs (heparin, warfarin, clopidogrel)
- Ethical and/or religious objection to receiving blood products
- International patients
- Patients undergoing revision surgery
- Patients undergoing combined PAO and other surgeries such as surgical dislocation, proximal femoral osteotomy
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 23 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03823417
Start Date
July 1 2019
End Date
July 23 2019
Last Update
October 4 2019
Active Locations (1)
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1
Boston children hospital
Boston, Massachusetts, United States, 02115