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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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).Check my eligibility
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.See study design
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 belowSelect...
I had jaw surgery at UAB Highlands Hospital.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Estimated Blood Loss
Mean Arterial Pressure
Surgeon's Analysis of Surgical Field Visualization
Trial Design
1Treatment groups
Experimental Treatment
Group I: Patients Receiving Tranexamic Acid with Avoidance of Hypotensive AnesthesiaExperimental Treatment2 Interventions
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Who is running the clinical trial?
University of Alabama at BirminghamLead Sponsor
1,594 Previous Clinical Trials
2,283,045 Total Patients Enrolled
Brian Kinard, DMD, MDPrincipal InvestigatorUniversity of Alabama at Birmingham
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I had jaw surgery at UAB Highlands Hospital.I have a bleeding disorder.I have a history of high blood pressure or heart issues.I cannot take TXA due to medical reasons.
Research Study Groups:
This trial has the following groups:- Group 1: Patients Receiving Tranexamic Acid with Avoidance of Hypotensive Anesthesia
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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