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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-19

Study Completion Date

2016-08-16

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Pharmacological Action

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type 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).

Sodium Chloride 0,9%

an equivalent volume 0.9 % Sodium Chloride.

Group Type PLACEBO_COMPARATOR

Sodium Chloride 0,9%

Intervention Type DRUG

Sodium Chloride 0,9%

Interventions

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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).

Intervention Type DRUG

Sodium Chloride 0,9%

Intervention Type DRUG

Other Intervention Names

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TXA

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No