Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Spinal Stenosis Intervertebral Disc Displacement

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental

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.

Group Type EXPERIMENTAL

Wound topically irrigated with 500mg TXA

Intervention Type DRUG

Control

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.

Group Type OTHER

1mg/kg/hr TXA intravenous infusion till the last suture

Intervention Type DRUG

Interventions

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Wound topically irrigated with 500mg TXA

Intervention Type DRUG

1mg/kg/hr TXA intravenous infusion till the last suture

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No