Antifibrinolytic Agents, Blood Transfusion, Hemorrhage, Spinal Fusion
Conditions
Keywords
Spinal deformity correction, Surgical bleeding, Transfusion practice, Spinal Fusion, Antifibrinolytic Agents, Hemorrhage, Blood Transfusion
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.
Interventions
DRUGTranexamic 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.
DRUGfisiologic 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)
Sponsors
Hospital Vall d'Hebron
Hospital Clinic of Barcelona
Hospital Universitari de Bellvitge
Hospital Universitario Getafe
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the number of transfused units required during the intraoperative and postoperative period | 7 days postoperative period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Spain
Outcome results
None listed