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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)

Must not have

Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs

Patients with known coagulopathy disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-operative day 1, 2 and 3

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.

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.

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 below

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I am between 18 and 80 years old.

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I am scheduled for a major spine surgery involving 2 to 8 levels.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am allergic to TXA or I am on blood thinners.

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I have a known blood clotting disorder.

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I need surgery urgently or as an emergency.

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I am extremely overweight.

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I am unable or unwilling to give consent for treatment.

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My kidneys do not work well.

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My surgery is planned to last more than 6 hours.

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I have liver problems.

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I have a serious heart condition.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-operative day 1, 2 and 3 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Hematocrit level

Secondary study objectives

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

0 / 11Eligibility criteria met