NCT03011866

Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Intravenous Versus Topical Use of Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS) : A Prospective, Randomized, Double Blind, Head-to-head Comparison Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 176 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Spinal Stenosis
• Intervertebral Disc Displacement

Interventions

Type	Name	Description
DRUG	Wound topically irrigated with 500mg TXA
DRUG	1mg/kg/hr TXA intravenous infusion till the last suture

Timeline

• Start date: 2017-02-01
• Primary completion: 2018-12-01
• First posted: 2017-01-05
• Last updated: 2017-01-05