Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Tranexamic Acid

Criteria

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.