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

• Status: Completed
• Trial end date: 2014-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute
• Collaborators: Hospital Clinic of Barcelona; Hospital Universitari de Bellvitge; Hospital Universitario Getafe; Hospital Vall d'Hebron
• Treatments: Tranexamic Acid

Criteria

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