← Back to Search

Tranexamic Acid for Spinal Deformity

Phase 3
Recruiting
Led By Han Jo Kim, MD
Research Sponsored by Hospital for Special Surgery, New York
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18-80
Scheduled to undergo posterior long segment (≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint disease + fusion to pelvis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 72 hours postoperatively
Awards & highlights

Study Summary

This trial is testing whether using tranexamic acid (TXA) both intravenously and topically can decrease blood loss and transfusion requirements in adult patients compared to using TXA intravenously alone during posterior spinal surgery for adult deformity.

Who is the study for?
Adults aged 18-80 scheduled for long spinal fusion surgery due to scoliosis or degenerative joint disease, who are not on certain blood thinners, without recent heart issues, bleeding disorders, severe anemia, color vision problems, active cancer or leukemia. They mustn't have renal or liver insufficiency, seizure history or thromboembolic events within the past year.Check my eligibility
What is being tested?
The trial is testing if Tranexamic Acid (TXA), used topically as an add-on to its intravenous form can reduce blood loss and need for transfusions during adult spine deformity surgeries. It compares the effectiveness of topical TXA with a placebo in patients already receiving intravenous TXA.See study design
What are the potential side effects?
Tranexamic Acid may cause side effects such as nausea, diarrhea, seizures in rare cases especially in individuals with a history of seizures; it could also increase the risk of developing blood clots.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 80 years old.
Select...
I am scheduled for a major spine surgery for scoliosis or joint disease, including fusion to the pelvis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 72 hours postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 72 hours postoperatively for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Drain output
Secondary outcome measures
Length of stay
Perioperative adverse events
Perioperative blood drop
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ivTXA + topical TXAExperimental Treatment1 Intervention
TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2 mg/kg/hr maintenance dosing as per hospital protocol
Group II: IV TXA + topical placeboPlacebo Group1 Intervention
Placebo solution (200 cc sterile normal saline + placebo TXA ampule (normal saline) (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction. IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2mg/kg/hr maintenance dosing as per hospital protocol
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tranexamic acid
FDA approved

Find a Location

Who is running the clinical trial?

Hospital for Special Surgery, New YorkLead Sponsor
242 Previous Clinical Trials
61,802 Total Patients Enrolled
3 Trials studying Scoliosis
910 Patients Enrolled for Scoliosis
Han Jo Kim, MDPrincipal InvestigatorDepartment of Spine Surgery
1 Previous Clinical Trials
70 Total Patients Enrolled

Media Library

Tranexamic Acid 100 MG/ML Clinical Trial Eligibility Overview. Trial Name: NCT03553186 — Phase 3
Scoliosis Research Study Groups: IV TXA + topical placebo, ivTXA + topical TXA
Scoliosis Clinical Trial 2023: Tranexamic Acid 100 MG/ML Highlights & Side Effects. Trial Name: NCT03553186 — Phase 3
Tranexamic Acid 100 MG/ML 2023 Treatment Timeline for Medical Study. Trial Name: NCT03553186 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA cleared Tranexamic Acid 100 MG/ML for public consumption?

"Tranexamic Acid 100 MG/ML has received a safety score of 3 due to the fact that this is a Phase 3 trial. This signifies that, not only is there some data supporting efficacy, but also multiple rounds of data affirming its safety."

Answered by AI

How many people can join this research project?

"Yes, this study is still open and currently recruiting patients. The listing was created on July 11th, 2018 and updated as recently as August 11th, 2020. They are looking for 100 people to participate at 1 site."

Answered by AI

Is the data on Tranexamic Acid 100 MG/ML conclusive?

"Currently, there are 68 active studies involving Tranexamic Acid 100 MG/ML. Of these, 29 are in Phase 3. The largest number of sites for these trials is based out of Kansas City, but there are a total of 304 locations running these tests."

Answered by AI

Are geriatric patients applicable for this research?

"The aim of this clinical trial is to test the efficacy of the proposed intervention in patients that are at least 18 years old but no more than 80."

Answered by AI

Who meets the qualifications to participate in this research?

"This trial has a 100 patient quota and is currently looking for individuals who have experienced blood loss, surgery, and are between 18-80 years old."

Answered by AI

What indications does Tranexamic Acid 100 MG/ML commonly cover?

"Tranexamic Acid 100 MG/ML is a common medication used to treat hyperfibrinolysis, but it can also be given for other reasons like hemophilia, bleeding, or tooth extractions."

Answered by AI

Are there any vacancies for this research project?

"Yes, this is an ongoing trial that was posted on 7/11/2018 and updated as recently as 8/11/2022. They are enrolling 100 individuals at 1 location."

Answered by AI
~15 spots leftby Mar 2025