Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries
TARGETS
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
1 other identifier
interventional
176
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2016
CompletedFirst Posted
Study publicly available on registry
January 5, 2017
CompletedStudy Start
First participant enrolled
February 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedJanuary 5, 2017
January 1, 2017
1.8 years
December 16, 2016
January 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Since operation initiation till postoperative day 3 (POD3)
Secondary Outcomes (19)
Visible intraoperative blood loss
Since operation initiation till operation completion, an average of 120min
Visible postoperative blood loss within 24hrs
0- 24hrs postoperatively
Visible postoperative blood loss within 48hrs
0- 48hrs postoperatively
Combined visible perioperative blood loss
Since operation initiation till postoperative 48hrs
Total postoperative blood loss
0- 48hrs postoperatively
- +14 more secondary outcomes
Study Arms (2)
Experimental
EXPERIMENTALLoading 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.
Control
OTHERLoading 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 30755256DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 16, 2016
First Posted
January 5, 2017
Study Start
February 1, 2017
Primary Completion
December 1, 2018
Last Updated
January 5, 2017
Record last verified: 2017-01