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The Effectiveness Of Intravenous TXA on Reducing Perioperative Blood Loss For Patients Undergoing PAO

Bleeding Clinical Trial

Official title:
The Effectiveness Of Intravenous Tranexamic Acid (TXA) on Reducing Perioperative Blood Loss For Patients Undergoing Periacetabular Osteotomy (PAO): A Randomized Double Blind Placebo Controlled Trial

Clinical Trial 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 approved by the Food and Drug Administration (FDA) for the reduction of bleeding for many types of surgical procedures. TXA works by slowing the breakdown of blood clots and helps to prevent bleeding. From previous studies, TXA has been shown to effectively prevent bleeding in patients undergoing heart, spine and skull remodeling surgeries.

As PAO surgery has been associated with significant blood loss when compared to other types of joint surgeries. In order to try and avoid bleeding that may lead to complications, different strategies can be used. In this research study the investigators want to learn more about how a medication called tranexamic acid (TXA) could help reduce bleeding during PAO surgery.

Clinical Trial 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 intravenous infusion of TXA during surgery is effective compared to standard care (no TXA) in decreasing blood loss (measured; and calculated) and blood transfusion (autologous and allogenic) perioperatively in adolescents and young adults presenting for PAO surgery. The rate of blood loss over time will be measured and compared between groups with adjustment for length of surgery (time; hours) and body weight (kg). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03823417
Study type Interventional
Source Boston Children’s Hospital
Contact
Status Withdrawn
Phase Phase 4
Start date July 2019
Completion date July 23, 2019
View Details
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