Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Not Applicable

• Conditions: Spinal Stenosis; Intervertebral Disc Displacement
• Interventions: Drug: 1mg/kg/hr TXA intravenous infusion till the last suture; Drug: Wound topically irrigated with 500mg TXA

• Registration Number: NCT03011866
• Lead Sponsor: Peking Union Medical College Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-16
• Status Verified: 2017-01
• Study First Submitted QC: 2017-01-04
• Last Update Submitted: 2017-01-04
• Study First Posted: 2017-01-05
• Last Update Posted: 2017-01-05
• Study Start: 2017-02
• Primary Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	1mg/kg/hr TXA intravenous infusion till the last suture	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.
Experimental	Wound topically irrigated with 500mg TXA	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.

Primary Outcome Measures

Name	Time	Method
Perioperative Total blood loss (TBL)	Since operation initiation till postoperative day 3 (POD3)	TBL= PBV\*（hematocrit on postoperative day 3- preoperative hematocrit）/average hematocrit; Predicted blood volume(PBV)= k1\* height\^3(m)+ k2\* weight(kg)+ k3 (female: k1=0.3561， k2=0.03308， k3=0.1833, male: k1=0.3669， k2=0.03219， k3=0.6041)

Secondary Outcome Measures

Name	Time	Method
Visible postoperative blood loss within 24hrs	0- 24hrs postoperatively
Combined visible perioperative blood loss	Since operation initiation till postoperative 48hrs	Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs
Postoperative prothrombin time(PT)	Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative R time	Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative K time	Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative international normalized ratio(INR)	Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Visible postoperative blood loss within 48hrs	0- 48hrs postoperatively
Postoperative activated partial thromboplastin time(APTT)	Tested at operation completion, postoperative 24hrs and postoperative 48hrs
Postoperative lysis after 30 minutes(LY 30)	Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Perioperative transfusion amounts	Since operation initiation till postoperative 48hrs
Length of hospital stay	A single inpatient duration since the day of admission till the day of discharge, an average of 1 week	Length of hospital stay is calculated by subtracting day of admission from day of discharge.
Adverse event rates	Since operation initiation till postoperative 48hrs	Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.
Visible intraoperative blood loss	Since operation initiation till operation completion, an average of 120min
Postoperative hidden blood loss (HBL)	48hrs postoperatively	HBL=TBL- combined visible perioperative blood loss
Postoperative maximum amplitude (MA)	Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
Postoperative hemoglobin nadir	Since operation completion till postoperative 48hrs
Perioperative transfusion rates	Since operation initiation till postoperative 48hrs
Total postoperative blood loss	0- 48hrs postoperatively	Total postoperative blood loss= drainage day1(ml)\* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)\* drainage Hct day2(%)/blood Hct day2(%)
Postoperative fibrinogen level(Fbg)	Tested at operation completion, postoperative 24hrs and postoperative 48hrs