Hemorrhage Clinical Trial
Official title:
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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