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

NCT03823417 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2019-10-04

No results posted yet for this study

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

Interventions

DRUG

Tranexamic Acid

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

DRUG

Normal saline

Normal saline infusion

Sponsors & Collaborators

Principal Investigators

  • Susan Goobie, MD, FRPCP · Boston Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
13 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-07-31
Primary Completion
2019-07-23
Completion
2019-07-23
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03823417 on ClinicalTrials.gov