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

The Effect of Tranexamic Acid on Duration of Surgery, Bleeding and Complications. A Double Blind, Placebo-controlled, Randomised Study of Patients Undergoing Elective Lumbar Spine Surgery.

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.

Study Overview

• Status: Completed
• Conditions: Pharmacological Action
• Intervention / Treatment: Drug: Tranexamic Acid; Drug: Sodium Chloride 0,9%

Detailed Description

Study Design: Double-blind, randomized, placebo-controlled, parallel-group study.

Objective: To investigate the effect of tranexamic acid (TXA) compared to placebo in low-risk adult patients undergoing elective minor lumbar spine surgery on operative time, estimated blood loss and complications.

Summary of Background Data: Studies have shown that TXA reduces blood loss during major spine surgery. There are no studies on the effect of TXA in minor lumbar spine surgery on operative time, intraoperative and postoperative blood loss and complications.

Methods: We enrolled patients with ASA grades 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients with thromboembolic disease, coagulopathy, hypersensitivity to TXA or history of convulsion were excluded. 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).

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Middelfart, Denmark, 5500
    • Spine Center of Southern Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: TXA tranexamic acid; 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; 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).; Other Names: TXA
PLACEBO_COMPARATOR: Sodium Chloride 0,9%; an equivalent volume 0.9 % Sodium Chloride.	Drug: Sodium Chloride 0,9%; Sodium Chloride 0,9%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perioperative bleeding and occurrence of dural tear, Deep venous thrombosis T.	Intra-operative blood loss was estimated by adding the weight (1g=1mL) of swabs and blood in the suction bottle and subtracting all fluids added to the surgical field. Surgical drain volume was estimated visually at two and 18 hours post-operatively. Total volume of peri-operative blood loss was calculated as the volume of intraoperative blood loss plus the post-operative volume measured from the drain output.	Surgical drain volume was estimated visually at two and 18 hours post-operatively.

Collaborators and Investigators

• Sponsor: Karen Hoejmark Hansen
• Investigators: Study Chair: Mikkel Andersen, MD, Sygehus Lillebaelt

Publications and helpful links

General Publications

• 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 12:1-7. doi: 10.3171/2019.1.SPINE1814. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 19, 2015
• Primary Completion (ACTUAL): August 16, 2016
• Study Completion (ACTUAL): August 16, 2016

Study Registration Dates

• First Submitted: October 15, 2018
• First Submitted That Met QC Criteria: October 19, 2018
• First Posted (ACTUAL): October 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: TXA;decompression; discectomy; operative time; blood loss
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Tranexamic Acid
• Other Study ID Numbers: S-20150072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not decided yet, so no plan except publishing the result in a scientific paper.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No