Treatment for Degenerative Disc Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Iowa Hospitals and Clinics, Iowa City, IADegenerative Disc Disease3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM) - DiagnosticTest
Eligibility
18 - 90
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare the effects of tranexamic acid to placebo in patients undergoing lumber interbody fusion surgery.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 0 Secondary · Reporting Duration: Up to 7 days

Up to 7 days
Transfusion
Day 7
Blood Loss
Day 7
Delirium

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Treatment
1 of 2
Placebo
1 of 2

Active Control

Non-Treatment Group

300 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment · Has Placebo Group · Phase 2

TreatmentActiveComparator Group · 3 Interventions: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM), Tranexamic Acid, Visual Acuity Exam · Intervention Types: DiagnosticTest, Drug, DiagnosticTest
PlaceboPlaceboComparator Group · 3 Interventions: 3 Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM), Saline Solution, Visual Acuity Exam · Intervention Types: DiagnosticTest, Drug, DiagnosticTest

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 7 days

Who is running the clinical trial?

Catherine R. OlingerLead Sponsor
Royce W. Woodroffe, MDLead Sponsor
Mario ZanatyLead Sponsor
Catherine Olinger, M.D.Principal InvestigatorUniversity of Iowa
Mario Zanaty, M.D>Principal InvestigatorUniversity of Iowa
Royce Woodroffe, M.D.Principal InvestigatorUniversity of Iowa

Eligibility Criteria

Age 18 - 90 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a condition called DDD and have undergone two or more levels of lumbar interbody fusion surgery, such as PLIF or TLIF.

Frequently Asked Questions

Has this medication been deemed safe by the FDA?

"This treatment received a score of 2, as there is some evidence pointing to its safety but it has not been proven effective yet." - Anonymous Online Contributor

Unverified Answer

Could I possibly qualify to take part in this experiment?

"The study team is looking for 300 individuals that have intervertebral disc degeneration and meet the following conditions: being between 18-90 years old, having an American Spinal Injury Association (ASIA) Impairment Scale anesthesia risk of I to IV, having a Body Mass Index (BMI) below 35, needing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF., and finally candidates must have failed conservative management such as physical therapy (PT) or occupational therapy (OT)." - Anonymous Online Contributor

Unverified Answer

Are there precedents for this proposed treatment plan?

"At the moment, there are 68 different clinical trials underway that are studying this treatment. Of these active studies, 29 are in Phase 3 and they're based all over the world in 304 different locations with a majority being concentrated in Kansas City, Kansas." - Anonymous Online Contributor

Unverified Answer

Under what circumstances would this medication be given to a patient?

"This medical intervention is used to treat hyperfibrinolysis. It can also be employed in cases like hemophilia, where there is abnormal bleeding, and during tooth extractions." - Anonymous Online Contributor

Unverified Answer

Are there any more open spots in this clinical trial for patients who wish to enroll?

"The clinicaltrials.gov listing for this trial shows that it is open and recruiting patients. This 300-person study was posted on August 1st, 2020 and last updated on October 13th, 2020 at a single site." - Anonymous Online Contributor

Unverified Answer

Could you tell me if people who are under 25 years old can participate in this clinical trial?

"This study's age requirements are that potential participants must be between 18-90 years old." - Anonymous Online Contributor

Unverified Answer

How many people are in this clinical trial?

"That is correct, the online clinicaltrial.gov registry has this listed as an ongoing study that began recruitment on 8/1/2020. The last update was 10/13/2022 and they are looking for 300 participants at 1 locations." - 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.