CLINICAL TRIAL

Tranexamic Acid for Fracture of Posterior Wall of Acetabulum

Recruiting · 18+ · All Sexes · Cincinnati, OH

Impact of Topical Tranexamic Acid on Pre- and Post-operative Hemoglobin/Hematocrit

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About the trial for Fracture of Posterior Wall of Acetabulum

Eligible Conditions
Fracture of Posterior Wall of Acetabulum · Fractures, Bone

Treatment Groups

This trial involves 2 different treatments. Tranexamic Acid is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Tranexamic Acid
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Normal saline
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic Acid
2011
Completed Phase 4
~2630

Side Effect Profile for Tranexamic Acid

Tranexamic Acid
Show all side effects
Myocardial infaction
8%
Postoperative wound infection
8%
Postoperative wound infection after release from hospital
8%
This histogram enumerates side effects from a completed 2015 Phase 4 trial (NCT02063035) in the Tranexamic Acid ARM group. Side effects include: Myocardial infaction with 8%, Postoperative wound infection with 8%, Postoperative wound infection after release from hospital with 8%.

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Patients must be skeletally mature.
Patients with an isolated, closed, posterior wall acetabular fracture managed surgically within 7 days of injury show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial

Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Postoperative Day 2
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Postoperative Day 2.
View detailed reporting requirements
Trial Expert
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- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Tranexamic Acid will improve 2 primary outcomes in patients with Fracture of Posterior Wall of Acetabulum. Measurement will happen over the course of Postoperative Day 2.

Hemoglobin (Hb)
POSTOPERATIVE DAY 2
Hemoglobin (Hb) results
Hematocrit (Hct)
POSTOPERATIVE DAY 2
Hematocrit (Hct) results

Who is running the study

Principal Investigator
M. A.
Prof. Michael Archdeacon, Professor & Chair
University of Cincinnati

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get fracture of posterior wall of acetabulum a year in the United States?

Every year approximately 3,400 fractures of the posterior wall of the acetabulum are treated in United States. Most of these are due to injury. Injury is often the mechanism of acetabular posterior wall fracture, resulting from falling, vehicular accidents or a direct impact to the posterior wall by a sharp blunt object and also due to impaction of the object into the acetabulum. The risk factors for fracture of posterior wall of acetabulum are mainly patient factors like age, gender, BMI and the person is less active than others of equal age or weight. Previous infection and history of osteomyelitis seem to be related to the posterior wall of the acetabulum fracture.

Anonymous Patient Answer

What causes fracture of posterior wall of acetabulum?

Fractures of posterior wall of acetabulum are an extremely rare injuries of the pelvis. The vast majority of patients with an acetabular posterior wall fractures are elderly and present with multiple other injury with multiple fractures to the same joint. There is also an association of posterior wall of acetabulum fracture in patient with Parkinson's disease and hip surgery. The posterior wall of acetabulum is a strong bony buttress which provides stability of acetabulum and serves to protect it from posterior dislocation. However, the mechanism of the injury to the posterior wall of acetabulum can be very complex and multifactorial.

Anonymous Patient Answer

Can fracture of posterior wall of acetabulum be cured?

Fracture needs surgical treatment because the patient was admitted to emergency and surgical suite for fracture. X-rays should be taken of the hip to reveal the causative factors.

Anonymous Patient Answer

What are the signs of fracture of posterior wall of acetabulum?

Patients with fracture of posterior wall of acetabulum should have a full clinical examination and imaging studies, including CT scan, to exclude occult bony, visceral, or pleural injury.

Anonymous Patient Answer

What are common treatments for fracture of posterior wall of acetabulum?

Fracture of posterior wall of acetabulum is common problem in China and can be repaired by open fractures repair. It may be treated by periacetabulum open-wedge plating or internal fixation with porous-coated screw.

Anonymous Patient Answer

What is fracture of posterior wall of acetabulum?

Osteopycnosis of posterior wall of acetabulum is commonly seen to be associated with osteoporotic bone fracture or osteoporotic vertebral fracture. However, it is not a typical pathologic finding for fracture of posterior wall of acetabulum. We also found that the fracture of posterior wall of acetabulum in patients with a history of acetabular dysplasia is significantly associated with rickets.

Anonymous Patient Answer

Does fracture of posterior wall of acetabulum run in families?

Findings from a recent study may suggest a genetic factor of fracture of posterior wall of acetabulum in families with a history of femoral neck fracture.

Anonymous Patient Answer

Has tranexamic acid proven to be more effective than a placebo?

The current study shows that TxA can prevent postoperative blood transfusion and its associated morbidity. This effect can be associated with the use of TxA, even for patients already receiving immunosuppressive therapy.

Anonymous Patient Answer

Is tranexamic acid safe for people?

The use of tranexamic acid in hip fracture patients did not reduce the rate of blood loss or transfusion needs at 7 days. A small but significant increase in major bleeding was found in the tranexamic acid group but this was not associated with an increase in blood loss. The tranexamic acid group did not show an increased rate of deep infection or hospital readmission at 8 months post-operatively.

Anonymous Patient Answer

What is tranexamic acid?

Tranexamic acid is an effective antifibrotic medication for the treatment of fracture fixation of the posterior wall of the acetabulum. Its low side effect profile is especially beneficial for these indications.

Anonymous Patient Answer

Who should consider clinical trials for fracture of posterior wall of acetabulum?

A fracture of posterior wall of acetabulum with deformity or avascular necrosis, or both, may not be considered for clinical trials due to its relatively low rate of improvement.

Anonymous Patient Answer

What is the average age someone gets fracture of posterior wall of acetabulum?

The mean age at the time of presentation for patients with intra-articular acetabular fracture is 61.4 y and that of extra-articular fractures is 44.5 y. The fracture of posterior wall of acetabulum is more common than previously reported (24.9%). In the current study, patients suffering from posterior wall of acetabulum fractures were seen to present more commonly than those in a previous study. It has to be kept in mind that the numbers of people with posterior wall fractures presenting to a hospital is extremely low, thus the mean age of presentation is considerably higher, when compared with the previous study.

Anonymous Patient Answer
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