Current Environment:

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.

Conditions

Bleeding

Recruitment Status

Withdrawn

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 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).

Eligibility Criteria

Inclusion Criteria:

ASA 1-2
Age 13-35 years
Scheduled for primary unilateral PAO +/- arthroscopy

Exclusion Criteria:

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

Intervention

Intervention Type

Intervention Name

Drug

Tranexamic Acid

Drug

Normal saline

Phase

Phase 4

Gender

All

Minimum Age

13 Years

Maximum Age

35 Years

Download Date

October 4, 2019

Principal Investigator

Susan Goobie

Primary Contact Information

For more information on this trial, visit clinicaltrials.gov.

Contact

For more information and to contact the study team: