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Antifibrinolytic Agent

Tranexamic acid for Spine Surgery

N/A

Recruiting

Research Sponsored by Rush University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days

Awards & highlights

Study Summary

This trial will help determine the best way to give tranexamic acid to patients undergoing open spine surgery to reduce the risk of transfusion and postoperative blood loss.

Eligible Conditions

Postoperative Blood Loss Following Spine Surgery

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Hemoglobin/Hematocrit

Transfusion

Secondary outcome measures

Cost comparison

Postoperative Complications

Side effects data

From 2012 Phase 4 trial • 100 Patients • NCT00740116

22%

Readmissions

14%

Postoperative infections

10%

Re-operations

Thromboembolic events

100%

80%

60%

40%

20%

Study treatment Arm

Placebo Group

Tranexamic Group

Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: Pre-Oral TXAExperimental Treatment1 Intervention

Three 650 mg tablets of oral TXA 2 hours prior to incision

Group II: IV TXAExperimental Treatment1 Intervention

1g IV TXA bolus will be given at the time of incision intraoperatively

Group III: Full Oral TXAExperimental Treatment1 Intervention

Three 650 mg tablets of oral TXA 2 hours prior to incision and three 650 mg tablets of oral TXA given each day for three days postoperatively (while in the hospital as an inpatient).

Group IV: No TXAActive Control1 Intervention

No preoperative, intraoperative, or postoperative tranexamic acid will be given

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tranexamic acid

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rush University Medical CenterLead Sponsor

422 Previous Clinical Trials

162,931 Total Patients Enrolled

Media Library

Tranexamic acid (Antifibrinolytic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04672213 — N/A

Blood Loss Following Spine Surgery Research Study Groups: Pre-Oral TXA, No TXA, IV TXA, Full Oral TXA

Blood Loss Following Spine Surgery Clinical Trial 2023: Tranexamic acid Highlights & Side Effects. Trial Name: NCT04672213 — N/A

Tranexamic acid (Antifibrinolytic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04672213 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the most comprehensive figure of individuals taking part in this clinical experiment?

"Affirmative. Evidence on clinicaltrials.gov states that this trial is presently seeking participants, which was initially posted on December 15th 2017 and recently updated on December 11th 2020. It requires 600 individuals from one centre to take part in the study."

Answered by AI

What conditions does Tranexamic acid typically alleviate?

"Tranexamic acid is often prescribed for the management of hyperfibrinolysis. It has also been noted to help with bleeding associated with hemophilia, extractions from dental work, and other related issues."

Answered by AI

Are there any positions still available in this clinical program?

"Affirmative. The website clinicaltrials.gov verifies that the trial is actively recruiting, with a post date of December 15th 2017 and an update on December 11th 2020. 600 patients need to be sourced from one medical centre for this study."

Answered by AI

Are there multiple investigations into the efficacy of Tranexamic acid?

"Currently, 61 Tranexamic acid studies are being conducted worldwide. Of those, 26 have progressed to Phase 3 human trials and 185 distinct clinical trial sites are located around the world with Kaohsiung City, Yanchao District housing many of them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TXA in Spine Surgery

Matthew Colman 2017. "TXA in Spine Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04672213.