The Effect of Tranexamic Acid. A Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.

NCT03714360 | Completed Phase 4 DMC

• 1 other identifier: S-20150072
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

In this randomized double blind placebo controlled study of tranexamic acid during minor spinal surgery, mean postoperative blood loss in the patients who received TXA was statistically significantly lower compared to placebo.

Conditions

Pharmacological Action

Keywords

TXA;decompression; discectomy; operative time; blood loss

Outcome Measures

Primary Outcomes (1)

• Operative time

  Defined as the time in minutes from incision to closure (last stitch)

  Intraoperative (The time in minutes from incision to closure (last stitch) was measured)

Secondary Outcomes (1)

• Perioperative bleeding and occurrence of dural tear, Deep venous thrombosis T.

  Surgical drain volume was estimated visually at two and 18 hours post-operatively.

Study Arms (2)

TXA tranexamic acid

EXPERIMENTAL

a single dose of 10 mg/kg of TXA, with a maximum dose of 1g. Administered as IV injection and marked as 'project-drug' and amount (mL) in the medical record.

Drug: Tranexamic Acid

Sodium Chloride 0,9%

PLACEBO COMPARATOR

an equivalent volume 0.9 % Sodium Chloride.

Drug: Sodium Chloride 0,9%

Interventions

Tranexamic Acid DRUG

patients with ASA(American Society of Anesthesiologists grades) 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo).

Also known as: TXA

TXA tranexamic acid

Sodium Chloride 0,9% DRUG

Sodium Chloride 0,9%

Sodium Chloride 0,9%

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients referred to the Centre for Spine Surgery and Research in the Region of Southern Denmark with symptomatic, MRI-verified lumbar spinal stenosis or disc herniations
• low risk (American Society of Anesthesiologists, ASA, score 1-2) adult patients scheduled for elective primary decompression or/and discectomy over one to two vertebral levels (without fusion or instrumentation), willing to give informed consent.

You may not qualify if:

• Not able to understand verbal and/or written Danish ASA score more than 2 Malignant disease Pregnancy Breast feeding
• Contraindications to TXA:
• Active thromboembolic disease Coagulopathy History of venous or arterial thrombosis Hypersensitivity to the active substance Disseminated intravascular coagulation Severe renal impairment History of convulsions ASA - American Society of Anesthesiologists score, TXA - Tranexamic acid.

Sponsors & Collaborators

• Mikkel Østerheden Andersen: lead

Study Sites (1)

Spine Center of Southern Denmark

Middelfart, 5500, Denmark

Location

Related Publications (1)

• Elmose S, Andersen MO, Andresen EB, Carreon LY. Double-blind, randomized controlled trial of tranexamic acid in minor lumbar spine surgery: no effect on operative time, intraoperative blood loss, or complications. J Neurosurg Spine. 2019 Apr 12;31(2):194-200. doi: 10.3171/2019.1.SPINE1814. Print 2019 Aug 1.

  PMID: 30978683 DERIVED

MeSH Terms

Conditions

Hemorrhage

Interventions

Tranexamic Acid

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Mikkel Andersen, MD

  Sygehus Lillebaelt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 15, 2018
• First Posted: October 22, 2018
• Study Start: October 19, 2015
• Primary Completion: August 16, 2016
• Study Completion: August 16, 2016
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

DK (1)