Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Unknown

Conditions: Spinal Stenosis; Intervertebral Disc Displacement

Treatments: Drug: 1mg/kg/hr TXA intravenous infusion till the last suture; Drug: Wound topically irrigated with 500mg TXA

Study type: Interventional

Funder types: Other

Identifiers

NCT03011866

PUMCH-000391

Details and patient eligibility

About

Multilevel decompression and bone graft fusion is a most effective measure for treating degenerative lumbar spinal diseases. Yet, the surgery is commonly associated with large amount of perioperative blood loss and high demand for homologous blood transfusion. Tranexamic acid (TXA) has been proved as efficient in reducing the gross blood loss in various kinds of surgeries. However, high quality evidence of its efficacy and safety is still lacking in lumbar spinal surgeries. Besides, systemic use of TXA carries the risks of thromboembolic complications such as deep venous thrombosis and pulmonary embolism, thus the optimal drug delivery route of TXA remains undetermined. The aim of this study is to test the non-inferiority of topical TXA application to its intravenous use in multilevel decompression and bone graft fusion surgeries. A prospective, randomized, double-blind, head-to-head comparison study design will be adopted.

Enrollment: 176 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologists(ASA)classification of physical status I-II.
• Aged over 50yrs.
• Patients suffering from spinal stenosis or intervertebral disc displacement and require multilevel decompression and bone graft fusion surgeries.
• Written informed consent.

Exclusion criteria

• ASA III-IV.
• Age≤ 50yrs.
• History of chronic renal dysfunction (preoperative blood creatinine> 120mmol/L), liver dysfunction (preoperative blood aspartate or alanine aminotransferase> 50 units/L) or history of coronary artery disease with stent placement.
• Abnormal preoperative coagulation profile (preoperative prothrombin time elongation> 3s, activated partial thromboplastin time elongation> 10s, platelet counts< 100*10^9/L or >400*10^9/L, or INR> 1.4).
• Pre-existing anemia (male< 12g/dL, female<11g/dL).
• Long-term medications of aspirin and/or other anticoagulants.
• Patients known as allergic to TXA.
• Patients who have religious and/or other beliefs limiting blood transfusion.
• Dura mater laceration and/or unexpected massive bleeding during operation.
• Cell saver application during operation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 2 patient groups

Experimental

Experimental group

Description:

Loading dose: 100ml 0.9% normal saline(NS) intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 5ml/hr 0.9% NS intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 500mg TXA in 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.

Treatment:

Drug: Wound topically irrigated with 500mg TXA

Control

Other group

Description:

Loading dose: 10mg/kg tranexamic acid(TXA) in 100ml 0.9% NS intravenous infusion, 15-20min prior to operation initiation. Maintenance dose: 1mg/kg/hr TXA intravenous infusion till the last suture. Bolus dose: the wound topically irrigated with 250ml 0.9% NS for 5min. Waste fluid was then removed by suction, and the wound was closed.

Treatment:

Drug: 1mg/kg/hr TXA intravenous infusion till the last suture