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Tranexamic Acid in Reducing Gross Hemorrhage and Transfusions of Spine Surgeries

NCT03011866 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 176

Last updated 2017-01-05

No results posted yet for this study

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.

Conditions

  • Spinal Stenosis
  • Intervertebral Disc Displacement

Interventions

DRUG

Wound topically irrigated with 500mg TXA

DRUG

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

Sponsors & Collaborators

  • Peking Union Medical College Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-28
Primary Completion
2018-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03011866 on ClinicalTrials.gov