Spinal Stenosis Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT06290908 -
RPE-P/TLIF for Lumbar Spinal Stenosis With Instability
|
||
| Withdrawn |
NCT03223701 -
Efficacy of Using Solum IV and BMC With GFC in TLIF
|
Phase 4 | |
| Recruiting |
NCT03883022 -
Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery
|
N/A | |
| Completed |
NCT02902380 -
The Effect of Dexmedetomidine on Neuroendocrine Stress Hormone Release and Heart Rate Variability in Patients Undergoing Major Spinal Surgery
|
N/A | |
| Not yet recruiting |
NCT06024785 -
Vertebropexy - Randomized-controlled Trial
|
N/A | |
| Not yet recruiting |
NCT06000319 -
Natural Matrix Protein™ (NMP™) Fibers in Cervical and Lumbar Interbody Fusion
|
||
| Completed |
NCT02558621 -
New Robotic Assistance System for Spinal Fusion Surgery
|
N/A | |
| Completed |
NCT02454400 -
Pre-surgery Physiotherapy for Patients With Specific Low Back Pain
|
N/A | |
| Completed |
NCT01377623 -
Pilot Study on the Effect of Dexmedetomidine on Inflammatory Responses in Patients Undergoing Lumbar Spinal Fusion
|
N/A | |
| Completed |
NCT00996073 -
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
|
Phase 2 | |
| Terminated |
NCT00974623 -
Bone Graft Materials Observational Registry
|
N/A | |
| Completed |
NCT00320619 -
Epsilon-Aminocaproaic Acid to Reduce the Need for Blood Transfusions During and Following Spine Surgery
|
N/A | |
| Completed |
NCT00022776 -
Surgical Versus Nonsurgical Treatment for Spinal Stenosis
|
Phase 3 | |
| Completed |
NCT06060821 -
Validity and Reliability of the 2-minute Step Test in Patients With Lumbar Spinal Stenosis
|
||
| Recruiting |
NCT04552145 -
Physical Therapy vs Surgical Decompression for Lumbar Spinal Stenosis
|
N/A | |
| Active, not recruiting |
NCT04379921 -
Improving Spine Surgical Care With Real-Time Objective Patient Tracking Using the Apple Watch
|
N/A | |
| Withdrawn |
NCT04315090 -
Post-surgical Outcomes Measure Using the ERAS Protocol for Posterior Cervical Decompression and Fusion
|
||
| Completed |
NCT04591249 -
Physical Activity Intervention for Patients Following Lumbar Spine Surgery
|
N/A | |
| Recruiting |
NCT04601363 -
Personalized Spine Study Group (PSSG) Registry
|
||
| Completed |
NCT04193488 -
Mid-Transverse Process to Pleural (MTP) Block and Erector Spinal Plan (ESP) Block in Spinal Surgery
|
N/A |