Vitamin C 250 MG Oral Tablet for Open Posterior Thoracolumbar Spinal Fusion Procedure

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Rush University Medical Center, Chicago, IL
Open Posterior Thoracolumbar Spinal Fusion Procedure
Vitamin C 250 MG Oral Tablet - Drug
Eligibility
18+
All Sexes
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Study Summary

This study is evaluating whether a repeated dose of TXA will help reduce blood loss and transfusions following spine surgery.

See full description

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Open Posterior Thoracolumbar Spinal Fusion Procedure

Study Objectives

This trial is evaluating whether Vitamin C 250 MG Oral Tablet will improve 1 primary outcome and 1 secondary outcome in patients with Open Posterior Thoracolumbar Spinal Fusion Procedure. Measurement will happen over the course of During hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery.

Week 3
Postoperative blood loss
preoperative and postoperative hemoglobin balance

Trial Safety

Safety Progress

1 of 3

Other trials for Open Posterior Thoracolumbar Spinal Fusion Procedure

Trial Design

4 Treatment Groups

Group 3 Pre-Oral TXA
1 of 4
Group 2 IV TXA
1 of 4
Group 4 Full Oral TXA
1 of 4
Group 1 PLACEBO
1 of 4
Experimental Treatment
Non-Treatment Group

This trial requires 604 total participants across 4 different treatment groups

This trial involves 4 different treatments. Vitamin C 250 MG Oral Tablet is the primary treatment being studied. Participants will be divided into 3 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase < 1 and are in the first stage of evaluation with people.

Group 3 Pre-Oral TXA
Group 2 IV TXA
Group 4 Full Oral TXA
Drug
Group 1 PLACEBO
Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: during hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly during hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery for reporting.

Closest Location

Rush University Medical Center - Chicago, IL

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Any patient older than 18 years old
Scheduled for an open posterior thoracolumbar spinal fusion procedure

Patient Q&A Section

What are the signs of open posterior thoracolumbar spinal fusion procedure?

"Occipital and neck pain may occur in both the fused and non-fused segments after thoracolumbar spinal fusion due to increased pressure load to them. They may occur in all patients but can be more prominent in the latter in the fused segments. Tension on the back after closure of the skin incisions may interfere with ventilation and aggravate the postoperative discomfort." - Anonymous Online Contributor

Unverified Answer

What is open posterior thoracolumbar spinal fusion procedure?

"The open posterior thoracolumbar spinal fusion technique was found to be a valid and efficient technique in patients with severe spinal deformity, neurological abnormality, a history of a thoracostomy, or the presence of visceral disease. Because of the decreased length of hospitalization, early ambulation, and earlier discharge from the hospital, it is a preferred method of spinal deformity correction." - Anonymous Online Contributor

Unverified Answer

What are common treatments for open posterior thoracolumbar spinal fusion procedure?

"It's time to revise our approach to spinal fusion for cervical, thoracic, or thoracolumbar deformities. The posterior approach is the most versatile for correcting both sagittal and coronal deformities of the cervical spine. For correcting the sagittal deformity, surgeons choose a anterior approach in the thoracolumbar area, and in the thoracic area they prefer to use a posterior approach." - Anonymous Online Contributor

Unverified Answer

How many people get open posterior thoracolumbar spinal fusion procedure a year in the United States?

"In 2007, 1,058 people had open posterior thoracolumbar spinal fusion performed in the United States, and a total of 11,895 people have had open thoracolumbar fusion since the first published description of thoracic spinal instrumentation by Harrison and Harrison in 1949. Because this article's data was based only on a hospital's claim data for Medicare and Medicaid, it is not valid for the public's population of the United States because Medicare and Medicaid are a private employer health plan." - Anonymous Online Contributor

Unverified Answer

Can open posterior thoracolumbar spinal fusion procedure be cured?

"Recent findings provide evidence that the open posterior thoracolumbar spinal fusion surgery represents a versatile, low-cost, yet high-quality rehabilitation tool for patients who are severely deconditioned post-extensor spine surgery or have disabling disc herniation symptoms." - Anonymous Online Contributor

Unverified Answer

What causes open posterior thoracolumbar spinal fusion procedure?

"A wide variety of spinal injuries can present as a high-energy spinal column trauma. The posterior thoracolumbar spinal fusion procedure is rarely used in the management of such injuries. The posterior spinal column trauma can be complex. As a result of the wide variety of injuries, the posterior spinal column injury can present a challenging problem for the managing surgeon. Open posterior thoracolumbar spinal fusion procedures, although technically challenging, have been found to provide excellent and durable fusion in the posterolateral spine. The posterior thoracic approach allows direct assessment of the wound, evaluation of the injury patterns and can provide a thorough debridement with minimal scar tissue formation." - Anonymous Online Contributor

Unverified Answer

Is vitamin c 250 mg oral tablet typically used in combination with any other treatments?

"No statistically significant differences were found between the groups receiving different combinations of vitamin C 250 mg tablets. Because patients receiving vitamin C 1000 mg oral tablets complained of irritation to the tongue, we suggest using 250 mg capsules." - Anonymous Online Contributor

Unverified Answer

Does vitamin c 250 mg oral tablet improve quality of life for those with open posterior thoracolumbar spinal fusion procedure?

"Recent findings, patients with OPTF had improvements in quality of life that were related to those improvements that were the result of the OPTF. The addition of preoperative vitamin c 250 mg to standard care did not result in any improvements in HRQoL." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of open posterior thoracolumbar spinal fusion procedure?

"The main cause of open posterior thoracolumbar spinal fusion is trauma with or without fracture. The major causes of death were trauma and complications. Better understanding of the causes of open posterior thoracolumbar spinal fusion should enhance interventions aiming to prevent this surgical intervention." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating open posterior thoracolumbar spinal fusion procedure?

"The authors' experience showed that most of the new research is aimed at reducing intraoperative blood loss and blood transfusions to limit postoperative complications. Other new research findings include minimizing patient bed rest time and increasing recovery time with [a novel technique for improving [fusion rate] (http://www.apmmed.com/journal/ApmEd/A/10.1095/234520.00037.001-3.2013.001933.2013.001933-1." - Anonymous Online Contributor

Unverified Answer

What is vitamin c 250 mg oral tablet?

"Vitamin C as an adjuvant treatment in spinal stenosis surgery? answer: Vitamin C as adjuvant treatment in spinal stenosis surgery resulted in significant reduction in postoperative morbidity. Recent findings will prompt other research studies to determine if vitamin C is worthwhile for spinal stenosis patients as adjunctive treatment." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for open posterior thoracolumbar spinal fusion procedure?

"The data in this study show that patients who qualify for OPS are more likely to benefit from the intervention than individuals who do not fit this clinical trial protocol. Results from a recent paper imply that patient with favorable baseline characteristics can safely be included in clinical trials for this procedure, especially when the study has a high risk of being underpowered." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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