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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
96
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.
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)
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Hospital Vall d'Hebron de Barcelona
Barcelona, Barcelona, Spain
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital de Getafe
Getafe, Madrid, Spain
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
Time frame: 7 days postoperative period
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.
Time frame: 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
Time frame: up to 6 weeks after the procedure
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