Topical Tranexamic Acid in Reducing post-operative Blood Loss in thoraco-lumbar spine injury

Phase 4

Completed

• Conditions: - reduce post- operative blood loss- reduce blood transfusion; topical tranexemic acid; thoraco- lumbar spine injury without neurodeficit

• Registration Number: TCTR20160412001
• Lead Sponsor: none

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04-12
• Study Completion: 2016-09-30
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

a.Men and women, 18 to 70 years of age with injuries involving the thoracic or lumbar spine (Thoracolumbar Injury Classification and Severity score  5) undergoing long-segment (4 levels) instrumented posterior spinal fusion with local autologous bone graft
b.No neurological deficits
c.American Society of Anesthesiologists physical status class I, II or III

Exclusion Criteria

a.Renal insufficiency
b.History of thromboembolic events (e.g., pulmonary embolism, embolic stroke, and deep venous thrombosis)
c.History of significant cardiovascular diseases (e.g., unstable angina, recent myocardial infarction, significant arrhythmia, and uncontrolled hypertension)
d.History of acquired defective color vision
e.Coagulation disorder
f.Gross hematuria or microhematuria
g.Dural tear
h.Allergy to tranexamic acid
i.Take aspirin or nonsteroidal anti-inflammatory drugs within a week before randomization and during the study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Postoperative PRC transfusion day 1,2,3 postoperatively unit

Secondary Outcome Measures

Name	Time	Method
postoperative blood loss day 1,2,3 postoperatively ml.