Clinical trial NCT01136590: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Spinal Fusion
Antifibrinolytic Agents
Hemorrhage
Blood Transfusion
Keywords: Spinal deformity correction
Surgical bleeding
Transfusion practice
Spinal Fusion
Antifibrinolytic Agents
Hemorrhage
Blood Transfusion
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Hospital Vall d'Hebron
name: Hospital Clinic of Barcelona
name: Hospital Universitari de Bellvitge
name: Hospital Universitario Getafe
First posted: 2010-06-03
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period
timeFrame: 7 days postoperative period
Secondary outcomes:
measure: Total blood loss: intraoperative and postoperative values
timeFrame: 48 hours postoperative
measure: Adverse events in the perioperative period, immediate postoperative period, and at mid-term
timeFrame: up to 6 weeks after the procedure
Other outcomes:
Locations:
city: Hospitalet de Llobregat
country: Spain
facility: Hospital de Bellvitge
state: Barcelona
city: Getafe
country: Spain
facility: Hospital de Getafe
state: Madrid
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron de Barcelona
Study officials:
affiliation: Hospital Vall d'Hebron
name: Maria J Colomina, MD Ph
role: STUDY_CHAIR
affiliation: Hospital Clinic of Barcelona
name: Misericordia Basora, MD Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: Maylin Koo, MD Ph
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Getafe.
name: Javier Pizones, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colomina MJ, Koo M, Basora M, Pizones J, Mora L, Bago J. Intraoperative tranexamic acid use in major spine surgery in adults: a multicentre, randomized, placebo-controlled trialdagger. Br J Anaesth. 2017 Mar 1;118(3):380-390. doi: 10.1093/bja/aew434.