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Antifibrinolytic Agent

Tranexamic Acid for Rotational Thromboelastometry (ROTEM)

N/A

Waitlist Available

Led By Uzung Yoon

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

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

Must have

The study population will include total of 200 adults (age range of 18 - 85 years) who are in the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3. Inclusion criteria are patients undergoing unilateral, primary, total hip arthroplasty.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 72-hour after surgery

Awards & highlights

Study Summary

This trial is investigating whether or not tranexamic acid, which is used to reduce blood loss, is necessary during total hip arthroplasty.

Eligible Conditions

Rotational Thromboelastometry (ROTEM)
Intravascular Coagulation
Fibrinolysis
Total Hip Replacement
Tranexamic Acid

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one hour after the end of surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one hour after the end of surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and one hour after the end of surgery for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Fibrinolysis

Secondary outcome measures

Blood loss

Hematoma

Thrombotic events (PE, DVT).

+3 more

Side effects data

From 2015 Phase 4 trial • 29 Patients • NCT02063035

Postoperative wound infection

Postoperative wound infection after release from hospital

Myocardial infaction

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Tranexamic Acid

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: tranexamic acidExperimental Treatment1 Intervention

Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language

Group II: Normal salinePlacebo Group1 Intervention

Patients undergoing unilateral, primary, total hip arthroplasty with English as their native language

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic Acid

2011

Completed Phase 4

~2740

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,664 Total Patients Enrolled

Uzung YoonPrincipal Investigator - Thomas Jefferson University

Thomas Jefferson University

Frequently Asked Questions

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

Does the minimum age criteria for this research include individuals below forty years old?

"Based on the parameters set forth, this medical trial is open to all individuals above 18 years and under 85."

Answered by AI

What medical conditions is Tranexamic Acid most commonly prescribed for?

"Tranexamic Acid is a commonly prescribed remedy for treating hyperfibrinolysis, as well as hemophilia, bleeding episodes, and post-tooth extraction haemorrhaging."

Answered by AI

How many individuals may participate in this trial at its peak?

"Indeed, the clinical trial is actively enrolling participants. It was initially published on May 20th 2019 and has seen its most recent update occur on September 23rd 2022. The study seeks to recruit 50 patients at a single medical centre."

Answered by AI

Is there opportunity for me to join in on this clinical investigation?

"This investigation is enlisting 50 individuals aged 18 to 85 who are taking tranexamic acid. Moreover, all participants must be within the American Society of Anesthesiologists (ASA) Physical Status (PS) 1-3 and currently undergoing unilateral, primary, total hip arthroplasty in order to qualify for inclusion in this study."

Answered by AI

Is this experiment currently enrolling participants?

"Data on clinicaltrials.gov reveals that this medical trial is still recruiting patients. It was first listed on the 20th of May 2019, and its most recent update occurred on September 23rd 2022."

Answered by AI

How widely has Tranexamic Acid been tested in clinical trials?

"Currently, 61 clinical trials investigating the effects of Tranexamic Acid are in progress with 26 studies in their final Phase. These research projects span 185 cities across the country, including Kansas City, Kansas."

Answered by AI

Recent research and studies

The Journal of Knee SurgeryJournal

Tranexamic Acid Effectively Reduces Blood Loss and Transfusion Rates During Simultaneous Bilateral Total Knee Arthroplasty

Prieto, Hernan, Heather Vincent, Justin Deen, Dane Iams, and Hari Parvataneni. 2017. “Tranexamic Acid Effectively Reduces Blood Loss and Transfusion Rates During Simultaneous Bilateral Total Knee Arthroplasty”. The Journal of Knee Surgery. Georg Thieme Verlag KG. doi:10.1055/s-0037-1603333.

Anesthesia & AnalgesiaJournal

The Accuracy of Blood Loss Estimation After Simulated Vaginal Delivery

Toledo, Paloma, Robert J. McCarthy, Bradley J. Hewlett, Paul C. Fitzgerald, and Cynthia A. Wong. 2007. “The Accuracy of Blood Loss Estimation After Simulated Vaginal Delivery”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/01.ane.0000286233.48111.d8.

Anesthesia & AnalgesiaJournal

Hyperfibrinolysis Diagnosed by Rotational Thromboelastometry (ROTEM®) Is Associated with Higher Mortality in Patients with Severe Trauma

Theusinger, Oliver M., Guido A. Wanner, Maximilian Y. Emmert, Adrian Billeter, Jennifer Eismon, Burkhardt Seifert, Hans-Peter Simmen, Donat R. Spahn, and Werner Baulig. 2011. “Hyperfibrinolysis Diagnosed by Rotational Thromboelastometry (ROTEM®) Is Associated with Higher Mortality in Patients with Severe Trauma”. Anesthesia & Analgesia. Ovid Technologies (Wolters Kluwer Health). doi:10.1213/ane.0b013e31822e183f.

Journal of Orthopaedic TraumaJournal