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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Bleeding

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 13 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients who choose to participate will be randomized to receive either: placebo i.e. saline 0.9% (intravenous injection) (Control Group) or intravenous TXA 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline placebo<br>the participant will get saline 0.9% intravenous infusion for the duration of the surgery | Drug: Normal saline<br>* Normal saline infusion<br>* Other names: placebo;|
| Experimental: Intravenous Tranexamic acid<br>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 | Drug: Tranexamic Acid<br>* Intravenous TXA 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<br>* Other names: TXA;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood loss | ml | 1 week after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma TXA level | ug/mL | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tranexamic Acid, Periacetabular Osteotomy, Bleeding