Clinical trial NCT03011866: Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Stenosis
Intervertebral Disc Displacement
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 176
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Perioperative Total blood loss (TBL)
timeFrame: Since operation initiation till postoperative day 3 (POD3)
Secondary outcomes:
measure: Visible intraoperative blood loss
timeFrame: Since operation initiation till operation completion, an average of 120min
measure: Visible postoperative blood loss within 24hrs
timeFrame: 0- 24hrs postoperatively
measure: Visible postoperative blood loss within 48hrs
timeFrame: 0- 48hrs postoperatively
measure: Combined visible perioperative blood loss
timeFrame: Since operation initiation till postoperative 48hrs
measure: Total postoperative blood loss
timeFrame: 0- 48hrs postoperatively
measure: Postoperative hidden blood loss (HBL)
timeFrame: 48hrs postoperatively
measure: Postoperative prothrombin time(PT)
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative activated partial thromboplastin time(APTT)
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative fibrinogen level(Fbg)
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative international normalized ratio(INR)
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs
measure: Postoperative R time
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative K time
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative maximum amplitude (MA)
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative lysis after 30 minutes(LY 30)
timeFrame: Tested at operation completion, postoperative 24hrs and postoperative 48hrs, using thromboelastography tests.
measure: Postoperative hemoglobin nadir
timeFrame: Since operation completion till postoperative 48hrs
measure: Perioperative transfusion rates
timeFrame: Since operation initiation till postoperative 48hrs
measure: Perioperative transfusion amounts
timeFrame: Since operation initiation till postoperative 48hrs
measure: Length of hospital stay
timeFrame: A single inpatient duration since the day of admission till the day of discharge, an average of 1 week
measure: Adverse event rates
timeFrame: Since operation initiation till postoperative 48hrs
Other outcomes:
Locations:
Study officials:
References:
citation: Hui S, Tao L, Mahmood F, Xu D, Ren Z, Chen X, Sheng L, Zhuang Q, Li S, Huang Y. Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries (TARGETS): study protocol for a prospective, randomized, double-blind, non-inferiority trial. Trials. 2019 Feb 12;20(1):125. doi: 10.1186/s13063-019-3231-9.