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Antifibrinolytic
Tranexamic Acid for Spinal Surgery
Phase < 1
Recruiting
Led By Yan Lai, M.D.
Research Sponsored by Icahn School of Medicine at Mount Sinai
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults 18-80 years old
Undergo major multilevel spine surgery (2-8 levels)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-operative day 1, 2 and 3
Awards & highlights
Study Summary
This trial is testing whether a medication called tranexamic acid can help reduce blood loss in people undergoing multi-level spine surgery. The study will compare different ways of administering the medication to see what works best.
Who is the study for?
Adults aged 18-80 scheduled for major multilevel spine surgery (2-8 levels) can join this trial. It's not for those with severe systemic disease, urgent surgeries, extreme obesity, clotting disorders, recent thromboembolic events, kidney or liver issues, TXA allergies, on blood thinners, unable to consent, serious heart conditions or beliefs against blood transfusion.Check my eligibility
What is being tested?
The study is testing if using tranexamic acid (TXA) topically and intravenously in low doses reduces blood loss more than just high or low dose TXA given intravenously during multi-level spine surgery. Patients are randomly assigned to one of the treatment groups.See study design
What are the potential side effects?
Tranexamic acid may cause side effects such as nausea and diarrhea. There might be risks related to clot formation due to its action on bleeding; however specific side effects will depend on individual patient factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 80 years old.
Select...
I am scheduled for a major spine surgery involving 2 to 8 levels.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-operative day 1, 2 and 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-operative day 1, 2 and 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Hematocrit level
Secondary outcome measures
Post-operative drain output
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose Intravenous TXA (lTXA group)Experimental Treatment2 Interventions
Patients assigned to lTXA group will receive 20mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.
Group II: High Dose Intravenous TXA (hTXA group)Experimental Treatment2 Interventions
Patients assigned to hTXA group will receive 50mg/kg IV TXA loading dose with a 5mg/kg/hr maintenance dose, and normal saline poured over 5 minutes at the wound prior to closure.
Group III: Combined Intravenous and Topical TXA group (cTXA group)Placebo Group2 Interventions
Patients assigned to cTXA group will received 20mg/kg V TXA loading dose with a 5mg/kg/hr maintenance dose, and 2g topical TXA poured over 5 minutes at the would prior to closure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Normal saline
2013
Completed Phase 4
~2090
Find a Location
Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,411 Total Patients Enrolled
Yan Lai, M.D.Principal InvestigatorMount Sinai West and Morningside Hospitals
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 18 and 80 years old.I am allergic to TXA or I am on blood thinners.I have a known blood clotting disorder.I am either male or female.I need surgery urgently or as an emergency.I am extremely overweight.I had a blood clot less than a year ago.I am unable or unwilling to give consent for treatment.My kidneys do not work well.You have a severe medical condition that affects your overall health.Your religious or other beliefs do not allow you to receive a blood transfusion.My surgery is planned to last more than 6 hours.I am scheduled for a major spine surgery involving 2 to 8 levels.I have liver problems.I have a serious heart condition.
Research Study Groups:
This trial has the following groups:- Group 1: Combined Intravenous and Topical TXA group (cTXA group)
- Group 2: High Dose Intravenous TXA (hTXA group)
- Group 3: Low Dose Intravenous TXA (lTXA group)
Awards:
This trial has 0 awards, including: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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
New York
What site did they apply to?
Mount Sinai West Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I've tried 2 medication and epidural and no change.
PatientReceived 1 prior treatment
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