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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136590
• Other study ID #: TRANEX2009
• Secondary ID: 2008-006938-94
• Status: Completed
• Phase: Phase 4
• First received: June 2, 2010
• Last updated: February 23, 2015
• Start date: September 2010
• Est. completion date: May 2014

Study information

• Verified date: February 2015
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Antifibrinolytic Agents
• Blood Transfusion
• Hemorrhage
• Spinal Fusion

Intervention

Drug:
• Tranexamic Acid
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.
• 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)

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Vall d'Hebron de Barcelona	Barcelona
Spain	Hospital de Getafe	Getafe	Madrid
Spain	Hospital de Bellvitge	Hospitalet de Llobregat	Barcelona

Sponsors (5)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute	Hospital Clinic of Barcelona, Hospital Universitari de Bellvitge, Hospital Universitario Getafe, Hospital Vall d'Hebron

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period		7 days postoperative period	No
Secondary	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	No
Secondary	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	Yes