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Antifibrinolytic Agent

Tranexamic Acid for Surgical Bleeding Control

Phase 4
Waitlist Available
Led By Brian Kinard, DMD, MD
Research Sponsored by University of Alabama at Birmingham
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Bimaxillary orthognathic surgery completed at UAB Highlands Hospital
Must not have
Bleeding diathesis
History of hypertension or previously diagnosed cardiac problems
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will compare the need for DHA when TXA is administered during orthognathic surgery. DHA has risks, so it may be safer to avoid it if TXA can control blood loss and provide good surgical site visualization.

Who is the study for?
This trial is for individuals undergoing bimaxillary orthognathic surgery at UAB Highlands Hospital. It's not suitable for those with high blood pressure, heart issues, bleeding disorders, or who can't safely receive tranexamic acid (TXA).
What is being tested?
The study is testing if using TXA during jaw surgery can control blood loss well enough to avoid the need for deliberately lowering blood pressure—anesthesia practice that reduces bleeding but has risks like kidney and heart problems.
What are the potential side effects?
While the summary doesn't specify side effects of TXA, common ones include nausea, vomiting, diarrhea. Risks related to avoiding hypotensive anesthesia might include increased bleeding compared to standard practices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I had jaw surgery at UAB Highlands Hospital.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a bleeding disorder.
Select...
I have a history of high blood pressure or heart issues.
Select...
I cannot take TXA due to medical reasons.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Estimated Blood Loss
Mean Arterial Pressure
Surgeon's Analysis of Surgical Field Visualization

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Patients Receiving Tranexamic Acid with Avoidance of Hypotensive AnesthesiaExperimental Treatment2 Interventions

Find a Location

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,640 Previous Clinical Trials
2,332,040 Total Patients Enrolled
Brian Kinard, DMD, MDPrincipal InvestigatorUniversity of Alabama at Birmingham

Media Library

Tranexamic Acid (Antifibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05474027 — Phase 4
Blood Loss Research Study Groups: Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia
Blood Loss Clinical Trial 2023: Tranexamic Acid Highlights & Side Effects. Trial Name: NCT05474027 — Phase 4
Tranexamic Acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05474027 — Phase 4
~17 spots leftby Dec 2025
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