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

Boston Children's Hospital

Status and phase: Withdrawn; Phase 4

Conditions: Bleeding

Treatments: Drug: Normal saline; Drug: Tranexamic Acid

Study type: Interventional

Funder types: Other

Identifiers

NCT03823417

IRB-P00030426

Details and patient eligibility

About

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.

Full 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).

Sex: All

Ages: 13 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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0 participants in 2 patient groups, including a placebo group

Normal saline placebo

Placebo Comparator group

Description:

the participant will get saline 0.9% intravenous infusion for the duration of the surgery

Treatment:

Drug: Normal saline

Intravenous Tranexamic acid

Experimental group

Description:

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

Treatment:

Drug: Tranexamic Acid