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Antifibrinolytic Agent
Tranexamic Acid for Spine Surgery Patients
Phase < 1
Recruiting
Led By Bryce Basques, MD
Research Sponsored by Rush University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Scheduled for an open posterior thoracolumbar spinal fusion procedure
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery
Awards & highlights
Study Summary
This trial is testing whether giving multiple doses of the drug tranexamic acid, either orally or by IV, can reduce blood loss and the need for transfusions after spine surgery.
Who is the study for?
This trial is for adults over 18 scheduled for open posterior thoracolumbar spinal fusion surgery. It's not suitable for those allergic to TXA, refusing blood products, with recent heart attacks, severe lung or liver disease, color vision issues, recent anticoagulant use, kidney impairment, pregnant or breastfeeding women, and those with a history of clotting disorders.Check my eligibility
What is being tested?
The study tests if multiple doses of oral Tranexamic Acid (TXA) can reduce post-surgery blood loss and transfusion needs compared to a single dose regimen. It also compares the effectiveness of oral TXA against intravenous delivery in patients undergoing spine surgery.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site from IV TXA and gastrointestinal discomfort from oral tablets. There could be an increased risk of clotting due to TXA's blood-clot preventing properties.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am scheduled for a specific back surgery involving the spine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative blood loss
Secondary outcome measures
preoperative and postoperative hemoglobin balance
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 4 Full Oral TXAExperimental Treatment1 Intervention
Group II: Group 3 Pre-Oral TXAExperimental Treatment2 Interventions
Group III: Group 2 IV TXAExperimental Treatment2 Interventions
Group IV: Group 1 PLACEBOPlacebo Group1 Intervention
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Who is running the clinical trial?
Rush University Medical CenterLead Sponsor
422 Previous Clinical Trials
162,897 Total Patients Enrolled
Bryce Basques, MDPrincipal InvestigatorRush University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently breastfeeding.I am scheduled for a specific back surgery involving the spine.You are pregnant.I have kidney problems.I have a severe lung condition.I choose not to participate in this trial.You are allergic to TXA.I refuse to receive blood transfusions.I am older than 18 years old.I haven't taken blood thinners within 5 days before my surgery.I have problems seeing colors correctly.I have severe heart disease that limits my daily activities.I have liver failure.I have had a heart attack before.You are sensitive or intolerant to Vitamin C.I have had blood clots or stroke-related conditions.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1 PLACEBO
- Group 2: Group 2 IV TXA
- Group 3: Group 3 Pre-Oral TXA
- Group 4: Group 4 Full Oral TXA
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.
Awards:
This trial has 0 awards, including:Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medicinal conditions is Vitamin C 250 MG Oral Tablet generally prescribed for?
"Vitamin C 250 MG Oral Tablet is often prescribed to treat iron deficiency anemia, vitamin A deficiencies, and hereditary angioedemas."
Answered by AI
What evidence exists for the efficacy of Vitamin C 250 MG Oral Tablet in medical research?
"Presently, 113 trials are being conducted to assess Vitamin C 250 MG Oral Tablet's efficacy. 34 of those active studies have reached Phase 3. Although most of these experiments occur in Kansas City, there are 659 other trial sites across the USA."
Answered by AI
What is the scale of enrollment for this clinical experiment?
"Affirmative. Clinicaltrials.gov displays that this research is presently in the process of recruiting participants, with it having been originally posted on August 26th 2019 and lastly updated on January 3rd 2022. This study requires 604 individuals to be recruited from a single facility."
Answered by AI
Is this scientific experiment recruiting participants currently?
"The data present on clinicaltrials.gov signals that this medical trial is currently searching for suitable participants; the initial post was made on August 26th 2019, with an update coming as recently as January 3rd 2022."
Answered by AI
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