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

Study Overview
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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.

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).

Official Title
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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.

Conditions
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Pharmacological Action

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Sodium Chloride 0,9%


Participation Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TXA tranexamic acid<br>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<br>* 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).<br>* Other names: TXA;|
| Placebo Comparator: Sodium Chloride 0,9%<br>an equivalent volume 0.9 % Sodium Chloride. | Drug: Sodium Chloride 0,9%<br>* Sodium Chloride 0,9%<br>|

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TXA;decompression; discectomy; operative time; blood loss