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Antifibrinolytic Agent

Tranexamic acid for Hip Fracture

Q: What is the current cohort size of this experimental research?

Affirmative, the information published on clinicaltrials.gov states that this medical trial is currently enlisting individuals for participation. It was first advertised on July 6th 2020 and has been updated as recently as July 18th 2022. The project requires 120 participants to be collected from a single site.

Q: Could you provide details of any past research projects involving Tranexamic acid?

Presently, Tranexamic acid is under investigation in 61 active clinical trials with 26 of them currently entering Phase 3. While <a href="https://www.withpower.com/clinical-trials/kansas">Kansas</a> City, Kansas has a notable number of studies underway for this medication, there are 185 other locations conducting research on it as well.

Q: Can new participants still join this medical experiment?

Affirmative. Clinicaltrials.gov shows that this study, which was originally posted on July 6th 2020, is actively enrolling participants. One medical centre needs to recruit 120 individuals for the trial.

Q: What has been the primary rationale for utilizing Tranexamic acid in medical treatments?

Tranexamic acid can be employed to treat hyperfibrinolysis, hemophilia, and other types of bleeding.

Q: What is the ultimate objective of this inquiry?

This trial seeks to measure the alteration in hemoglobin as its primary outcome, with venous thromboembolism (VTE), readmission within 30 days and any incidences of infection also being monitored. This assessment will take place over a four week period starting from when patients were randomized or discharged - whichever occurred first.

Phase < 1

Recruiting

Led By Michael Allen, DO

Research Sponsored by Community Memorial Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Femoral neck, intertrochanteric, subtrochanteric femur fracture

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up postoperative for 30 days

Awards & highlights

Study Summary

This trial will compare early administration of TXA in the ED (plus perioperative) versus perioperative administration only, to see if it reduces blood transfusion, blood loss, complications, length of stay, and readmission.

Eligible Conditions

Hip Fracture

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

You have broken your hip bone in the upper leg (femur) near the hip joint.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative for 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~postoperative for 30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative for 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in calculated and recorded hemoglobin

Total postoperative units of red blood cell transfusion

Secondary outcome measures

Infection

Other complications

Readmission

+1 more

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116

22%

Readmissions

14%

Postoperative infections

10%

Re-operations

Thromboembolic events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

Tranexamic Group

Trial Design

2Treatment groups

Experimental Treatment

Group I: Early TXAExperimental Treatment1 Intervention

Experimental group will receive 10 mg/kg IV TXA while in the Emergency Department, and repeat preoperative and postoperative doses.

Group II: ControlExperimental Treatment1 Intervention

Control group will receive 100 mL 0.9% normal saline in the Emergency Department, and 10 mg/kg IV TXA before skin incision and again in post anesthesia care unit.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

2018

Completed Phase 4

~42540

Normal Saline

2019

Completed Phase 4

~1770

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Community Memorial Health SystemLead Sponsor

2 Previous Clinical Trials

640 Total Patients Enrolled

Michael Allen, DOPrincipal Investigator - Resident physician

Memorial Regional Medical Center

Frequently Asked Questions

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

What is the current cohort size of this experimental research?

"Affirmative, the information published on clinicaltrials.gov states that this medical trial is currently enlisting individuals for participation. It was first advertised on July 6th 2020 and has been updated as recently as July 18th 2022. The project requires 120 participants to be collected from a single site."

Answered by AI

Could you provide details of any past research projects involving Tranexamic acid?

"Presently, Tranexamic acid is under investigation in 61 active clinical trials with 26 of them currently entering Phase 3. While Kansas City, Kansas has a notable number of studies underway for this medication, there are 185 other locations conducting research on it as well."

Answered by AI

Can new participants still join this medical experiment?

"Affirmative. Clinicaltrials.gov shows that this study, which was originally posted on July 6th 2020, is actively enrolling participants. One medical centre needs to recruit 120 individuals for the trial."

Answered by AI

What has been the primary rationale for utilizing Tranexamic acid in medical treatments?

"Tranexamic acid can be employed to treat hyperfibrinolysis, hemophilia, and other types of bleeding."

Answered by AI

What is the ultimate objective of this inquiry?

"This trial seeks to measure the alteration in hemoglobin as its primary outcome, with venous thromboembolism (VTE), readmission within 30 days and any incidences of infection also being monitored. This assessment will take place over a four week period starting from when patients were randomized or discharged - whichever occurred first."

Answered by AI

Recent research and studies

InjuryJournal

The Effect of Tranexamic Acid on Hidden Bleeding in Older Intertrochanteric Fracture Patients Treated with PFNA

Tian, Shuwei, Zheyuan Shen, Yang Liu, Yanlong Zhang, and Aqin Peng. 2018. “The Effect of Tranexamic Acid on Hidden Bleeding in Older Intertrochanteric Fracture Patients Treated with PFNA”. Injury. Elsevier BV. doi:10.1016/j.injury.2018.01.026.

Age and AgeingJournal

Anaemia Impedes Functional Mobility After Hip Fracture Surgery

Foss, N. B., M. T. Kristensen, and H. Kehlet. 2008. “Anaemia Impedes Functional Mobility After Hip Fracture Surgery”. Age and Ageing. Oxford University Press (OUP). doi:10.1093/ageing/afm161.

Geriatric Orthopaedic Surgery & RehabilitationJournal

Low Levels of Hemoglobin at Admission Are Associated with Increased 30-day Mortality in Patients with Hip Fracture

Praetorius, Katrine, Christian M. Madsen, Bo Abrahamsen, Henrik L. Jørgensen, Jes B. Lauritzen, and Anne Sofie B. Laulund. 2016. “Low Levels of Hemoglobin at Admission Are Associated with Increased 30-day Mortality in Patients with Hip Fracture”. Geriatric Orthopaedic Surgery & Rehabilitation. SAGE Publications. doi:10.1177/2151458516647989.

Journal of Orthopaedic SurgeryJournal