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

Phase 4

Completed

• Conditions: Spinal Fusion; Antifibrinolytic Agents; Hemorrhage; Blood Transfusion
• Interventions: Drug: fisiologic serum; Drug: Tranexamic Acid

• Registration Number: NCT01136590
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-02
• Study First Submitted QC: 2010-06-02
• Study First Posted: 2010-06-03
• Study Start: 2010-09
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	fisiologic serum	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)
tranexamic acid	Tranexamic Acid	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

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period	7 days postoperative period

Secondary Outcome Measures

Name	Time	Method
Total blood loss: intraoperative and postoperative values	48 hours postoperative	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.
Adverse events in the perioperative period, immediate postoperative period, and at mid-term	up to 6 weeks after the procedure	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

Trial Locations

Locations (4)

Hospital Vall d'Hebron de Barcelona; 🇪🇸 Barcelona, Spain

Hospital de Getafe; 🇪🇸 Getafe, Madrid, Spain

Hospital de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain