Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

Study Overview
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Brief Summary
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Current evidence regarding the efficacy and safety of perioperative administration of tranexamic acid for antifibrinolysis does not suffice to support its use in major spinal surgery. OBJECTIVES: To evaluate the effectiveness of tranexamic acid for decreasing transfusion requirements and bleeding in this patient population. To evaluate the safety of this antifibrinolytic agent in the intraoperative and mid-term postoperative period. METHODS: Multicenter, randomized, double-blind, placebo-controlled clinical trial with parallel groups. The main outcome measure is intraoperative and postoperative transfusion requirements; blood loss and safety will also be evaluated. Previous results in other types of surgery suggest that tranexamic acid reduces transfusion requirements and blood loss. Hence, the hypothesis of this study is that tranexamic acid will significantly reduce blood loss in comparison to a placebo in major spine surgery.

Official Title
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Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

Conditions
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Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: fisiologic serum


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients ≥18 years old of both sexes scheduled for complex spine surgery ASA I-III weighing more than 30 kg body mass index <30 kg/m2 operated on in the participating hospitals major spinal surgery signed an informed consent form to be included in the study Exclusion Criteria: a history of allergy or hypersensitivity to the agent used receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents) a history of frequent bleeding plasma creatinine values >1.5 mg/dL in the baseline analysis platelet count less than 150,000/mm3 in the follow-up analysis abnormal prothrombin time (INR >1.5) or partial thromboplastin time (INR >1.5) a history of a thromboembolic episode before surgery family history of thromboembolism lack of consent to participate in the study infectious disease, tumor or trauma of the spine as the reason for surgery scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tranexamic acid<br>tranexamic acid will be administered as a bolus (10-mg/kg dose ) or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery | Drug: Tranexamic Acid<br>* A 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery.<br>|
| Placebo Comparator: placebo<br>The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery) | Drug: fisiologic serum<br>* The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period |  | 7 days postoperative period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total blood loss: intraoperative and postoperative values | Intraoperative blood loss is evaluated by measuring the volume of suction aspirate and weighing the swabs with a precision digital scale. Postoperative blood loss is determined by recording the volume of blood collected through the suction drains at 24 and 48 hours. | 48 hours postoperative | 
| Adverse events in the perioperative period, immediate postoperative period, and at mid-term | Adverse events in the perioperative period, immediate postoperative period, and at mid-term (up to 6 weeks after the procedure) will be recorded, with special emphasis on follow-up of thrombotic events and clinically suspected deep venous thrombosis, renal function, and visual abnormalities reported by the patient | up to 6 weeks after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal deformity correction, Surgical bleeding, Transfusion practice, Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion