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RECRUITING Early Phase 1

Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery

NCT03849443 · View on ClinicalTrials.gov ↗

Study Summary

As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intravenous (IV) TXA reduces the postoperative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. The regimen that utilizes multiple doses of oral TXA will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen. Furthermore, oral TXA will be as efficacious as intravenous delivery of TXA.

Interventions

  • DRUG Tranexamic Acid Injectable Product (1000 mg intravenous bolus)
  • DRUG Vitamin C 250 MG Oral Tablet
  • DRUG Tranexamic Acid 650Mg Tablet

Study Locations (1)

Illinois

  • Rush University Medical Center — Chicago

Trial Details

FieldValue
Enrollment Target 604 participants
Start Date 2019-08-26
Est. Completion 2027-01-01
Phase Early Phase 1

Sponsor

Rush University Medical Center

168 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03849443

The ClinicalTrials.gov registry entry for NCT03849443 describes a study currently listed as recruiting. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 604 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rush University Medical Center, which has 168 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Open Posterior Thoracolumbar Spinal Fusion Procedure appearing as the primary indexed condition, and to 3 interventions — of which Tranexamic Acid Injectable Product (1000 mg intravenous bolus) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03849443 reports 1 study location spanning 1 distinct geographic area — top geographies include Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03849443 about?

NCT03849443 is a clinical study titled "Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery". As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intraven...

What is the current status of trial NCT03849443?

This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 604 participants. The study started on 2019-08-26. Estimated completion is 2027-01-01.

What conditions does trial NCT03849443 study?

This clinical trial studies the following conditions: Open Posterior Thoracolumbar Spinal Fusion Procedure. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03849443?

The interventions under investigation include: Tranexamic Acid Injectable Product (1000 mg intravenous bolus) (DRUG), Vitamin C 250 MG Oral Tablet (DRUG), Tranexamic Acid 650Mg Tablet (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03849443?

This trial is sponsored by Rush University Medical Center, which has 168 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03849443 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial