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

Phase 4

Withdrawn

• Conditions: Bleeding
• Interventions: Drug: Normal saline; Drug: Tranexamic Acid

• Registration Number: NCT03823417
• Lead Sponsor: Boston Children's Hospital

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 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.

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).

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Study First Posted: 2019-01-30
• Study Start: 2019-07
• Primary Completion: 2019-07-23
• Study Completion: 2019-07-23
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline placebo	Normal saline	the participant will get saline 0.9% intravenous infusion for the duration of the surgery
Intravenous Tranexamic acid	Tranexamic Acid	Intravenous TXA will be given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery

Primary Outcome Measures

Name	Time	Method
Blood loss	1 week after surgery	ml

Secondary Outcome Measures

Name	Time	Method
Plasma TXA level	24 hours	ug/mL

Trial Locations

Locations (1)

Boston children hospital; 🇺🇸 Boston, Massachusetts, United States