Combined IV and Topical TXA in Major Spine Surgery

NCT04797156 | Completed Early Phase 1 FDA Drug

• 1 other identifier: GCO 19-1137
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spine Surgery; Back Pain

Keywords

tranexamic acid; Spine surgery

Outcome Measures

Primary Outcomes (1)

• Change in Hematocrit level

  The amount of post-operative blood loss during the first 24, 48 and 72 hours in patients undergoing multilevel spine surgery. Specifically, the hematocrit number difference between baseline and post-operative day 1, 2 and 3.

  Baseline and Post-operative day 1, 2 and 3

Secondary Outcomes (1)

• Post-operative drain output

  Post-operative day 1, 2 and 3

Study Arms (3)

High Dose Intravenous TXA (hTXA group)

EXPERIMENTAL

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.

Drug: High Dose Tranexamic acid; Drug: Normal saline

Low Dose Intravenous TXA (lTXA group)

EXPERIMENTAL

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.

Drug: Low Dose Tranexamic acid; Drug: Normal saline

Combined Intravenous and Topical TXA group (cTXA group)

PLACEBO COMPARATOR

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

Drug: Low Dose Tranexamic acid; Drug: Tranexamic acid Topical

Interventions

High Dose Tranexamic acid DRUG

50mg/kg IV TXA

Also known as: hTXA

High Dose Intravenous TXA (hTXA group)

Low Dose Tranexamic acid DRUG

20mg/kg IV TXA

Also known as: lTXA

Combined Intravenous and Topical TXA group (cTXA group); Low Dose Intravenous TXA (lTXA group)

Tranexamic acid Topical DRUG

2g topical TXA

Also known as: TXA

Combined Intravenous and Topical TXA group (cTXA group)

Normal saline DRUG

Normal saline poured on wound

Also known as: NS

High Dose Intravenous TXA (hTXA group); Low Dose Intravenous TXA (lTXA group)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults 18-80 years old
• Undergo major multilevel spine surgery (2-8 levels)
• Male or female

You may not qualify if:

• ASA class V
• Urgent or emergent surgery,
• Morbid obesity
• Patients with known coagulopathy disorder, hx of thromboembolic event \<1 year, renal insufficiency, hepatic dysfunction, serious cardiac disease
• Patients with known allergy to TXA or receiving antiplatelet and/or anticoagulant drugs
• Religious or other belief that limit blood transfusion,
• Surgery duration more than 6 hours
• Patient refusal or inability to consent

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West Hospital

New York, New York, 10019, United States

Location

MeSH Terms

Conditions

Back Pain

Interventions

Tranexamic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Yan Lai, M.D.

  Mount Sinai West and Morningside Hospitals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: The patient, surgeon, and anesthesiologist in the case will be blinded
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Anesthesiology, Perioperative & Pain Medicine

Model Details: Patients will be assigned randomly using a computer-generated table of numbers to one of the three groups: 1. High Dose Intravenous TXA (hTXA group) 2. Low Dose Intravenous TXA (lTXA group) 3. Combined Intravenous and Topical TXA group (cTXA group).

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: March 3, 2021
• Primary Completion: August 15, 2024
• Study Completion: August 15, 2024
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)