Tranexamic Acid for Spinal Surgery

Recruiting in Palo Alto (17 mi)

Overseen by Yan Lai, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

This is a randomized study. The purpose of this study is to evaluate the effect of tranexamic acid in patients undergoing multilevel spine surgery. 75 patients undergoing multi-level spine surgery will be enrolled at Mount Sinai West. Study participation will last from the time of pre-operative evaluation to the time of discharge from hospital. Specifically, the study team will compare tranexamic acid given only intravenously vs. given both topically and intravenously vs. given only intravenously but at a higher dosage. The study team hypothesizes that patient who received combined topical and intravenous TXA (low dose) have similar or decreased overall blood loss postoperatively compared to patient who received high or low dose intravenous TXA alone.

Eligibility Criteria

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.

Inclusion Criteria

I am between 18 and 80 years old.

I am either male or female.

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

Exclusion Criteria

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

I have a known blood clotting disorder.

I need surgery urgently or as an emergency.

Participant Groups

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.

Group I: Low Dose Intravenous TXA (lTXA group) Experimental Treatment 2 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 Treatment 2 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 Group 2 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

Tranexamic acid is already approved in United States, European Union, Australia, Japan for the following indications:

🇺🇸 Approved in United States as Lysteda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma

🇪🇺 Approved in European Union as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

🇦🇺 Approved in Australia as Cyklokapron for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

🇯🇵 Approved in Japan as Nicolda for:

• Heavy Menstrual Bleeding
• Menstrual Disorders
• Bleeding Disorder
• Factor IX Deficiency
• Hemophilia A
• Melasma
• Postpartum hemorrhage

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Mount Sinai West Hospital New York, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai Lead Sponsor

References