Skip to main content
OpenTrials
Completed

NCT Number: NCT03714360

The Effect of Tranexamic Acid. A 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pharmacological Action Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Spine Center of Southern Denmark

Middelfart, 5500, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Other names: TXA

Sodium Chloride 0,9%

Drug

Sodium Chloride 0,9%

Primary outcomes

  1. Operative time

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

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

Secondary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Mikkel Østerheden Andersen

Other

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 22, 2018
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.