Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Peking Union Medical College Hospital176 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

176

Conditions

Spinal Stenosis Intervertebral Disc Displacement

Interventions

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Perioperative Total blood loss (TBL)

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)

Time frame: Since operation initiation till postoperative day 3 (POD3)

Secondary Outcomes

Visible intraoperative blood loss

Time frame: Since operation initiation till operation completion, an average of 120min

Visible postoperative blood loss within 24hrs

Time frame: 0- 24hrs postoperatively

Visible postoperative blood loss within 48hrs

Time frame: 0- 48hrs postoperatively

Combined visible perioperative blood loss

Combined visible perioperative blood loss= visible intraoperative blood loss + visible postoperative blood loss within 24hrs + visible postoperative blood loss within 48hrs

Time frame: Since operation initiation till postoperative 48hrs

Total postoperative blood loss

Total postoperative blood loss= drainage day1(ml)\* drainage Hct day1(%)/blood Hct day1(%)+ drainage day2(ml)\* drainage Hct day2(%)/blood Hct day2(%)

Time frame: 0- 48hrs postoperatively

Postoperative hidden blood loss (HBL)

HBL=TBL- combined visible perioperative blood loss

Time frame: 48hrs postoperatively

Postoperative prothrombin time(PT)

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs

Postoperative activated partial thromboplastin time(APTT)

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs

Postoperative fibrinogen level(Fbg)

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs

Postoperative international normalized ratio(INR)

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs

Postoperative R time

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.

Postoperative K time

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.

Postoperative maximum amplitude (MA)

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.

Postoperative lysis after 30 minutes(LY 30)

Time frame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.

Postoperative hemoglobin nadir

Time frame: Since operation completion till postoperative 48hrs

Perioperative transfusion rates

Time frame: Since operation initiation till postoperative 48hrs

Perioperative transfusion amounts

Time frame: Since operation initiation till postoperative 48hrs

Length of hospital stay

Length of hospital stay is calculated by subtracting day of admission from day of discharge.

Time frame: A single inpatient duration since the day of admission till the day of discharge, an average of 1 week

Adverse event rates

Adverse events include deep venous thrombosis, myocardial infarction, pulmonary embolism, cerebrovascular disease, impaired liver function, impaired renal function and incisional hematoma/ infection.

Time frame: Since operation initiation till postoperative 48hrs

Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts