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

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Bleeding

In brief

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.

Key facts

Study ID

NCT03823417

Run by

Boston Children's Hospital

People needed

0

Starts

2019-07-01

Expected to finish

2019-07-23

Last updated by the study team

2019-10-04

Who can join

Age: 13 and older, up to 35. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Boston children hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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